EC Certificate - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V
Supplementary Information to CE 69386
IssuedTo:
No.
Issued To:

CooperSurgical Inc.,
CE 69386
also trading as Ackrad Laboratories,
CooperSurgicalInc., Milex, Medscand,Prism Healthcare,alsoWallach
tradingSurgicalas Ackrad
Laboratories,
Devices,SAGE
In-Vitro Fertilization
and
Prism
Healthcare,
Milex, Medscand,
Lone SurgicalStar Medical
Products
WallachDevices,
95In-Vitro
Corporate
Drive, Trumbull,
SAGE
Fertilization
andConnecticut
Lone Star Medical Products
06611
95 Corporate
Drive, Trumbull,
USA

Connecticut
06611
USA
In respect of:

See certificate scope page.

on the basis of our examination of the quality assurance system under the requirements of Council Directive
93/42/EEC, Annex V. The quality assurance system meets the requirements of the directive. For the placing on themarket of class IIb and class III products an Annex III certificate is required.
For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797):

Gary E Slack, Senior Vice President Medical Devices
First Issued: 2002-08-30
First Issued: 2002-08-30

Date: 2020-03-13
Date: 2020-03-13

Expiry Date: 2024-05-26
Expiry Date: 2024-05-26

Page 1 of 4
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate No: CE 69386

Certificate Scope:
Supplementary Information to CE 69386

The manufacture of Ophthalmic, Gynaecology and dermatology Cryosurgery Systems andIssued To:
CooperSurgical Inc.,
accessories.
also trading as Ackrad Laboratories,
Prism Healthcare,
Medscand,The manufacture of sterile and non-sterile
obstetricsMilex,
and gynaecology
devices including;
Wallach Surgical Devices,•Uterine Manipulators/Injectors andtheiraccessories
including
SAGE
In-Vitro
Fertilizationand colpotomizer cups
Lone
Star
MedicalProducts•Vaginal Pessaries
95 Corporate Drive, Trumbull,•Amniocentesis Needles•Vacuum assisted Delivery systemsConnecticut
and accessories
06611•Infant warmers
USA•Fetal and Vascular Ultrasound Dopplers
The manufacture of sterile and non-sterile Artificial Reproductive Technology (ART) devices
including;•Oocyte recovery needles•Incubators•Micropipettes•Stripper Tips
The manufacture of sterile general surgery devices including;•Esophageal ballon Catheters•Laparoscopic cannulas/trocars•Laparoscopic Port Closure Systems•Stays, retractors and retractor kits
Those aspects of Annex V relating to securing and maintaining sterility in the manufacture of;Intrauterine Insemination Catheters, Embryo Replacement Catheters, Pasteur pipettes,
Assisted Hatching pipettes, Laparoscopic Smoke Evacuation Systems, Hysteroscopy
Saline/Air Contrast Injectors, Diagnostic Surveillance Cannulas, Adapter Drapes,
Hysterosalpingography Catheters, Bi-nasal Oxygen Cannulas, Cervical Dilators,
Gynaecological tissue sampling devices.
Those aspects of Annex V relating to metrology in the manufacture of;
Vaginal Pessary Fitting Kit and Contraceptive Diaphragm fitting sets

First Issued: 2002-08-30

Date: 2020-03-13

Expiry Date: 2024-05-26

Page 2 of 4
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Supplementary Information to CE 69386
Issued To:

NumberClass IIa
MD 1103
MD 1302
MD 1104
MD 1402
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0102
MD 0109
MD 0109
MD 0109

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Device Name

Intended purpose per IFU

Medical Heat Packs
Ultrasound dopplers
Cryosurgical systems
IVF Incubators G185 & G210
Adult Esophageal Balloon Catheter Set
Milex® Pessaries (Short term)
Uterine Manipulators/Injectors and Accessories
Fetal vacuum extraction system and Accessories
Carter-Thomason CloseSure System®
Stays and Retractors
Apple-Hunt Secondary Trocar Cannula
Carter-Thomason® II Port Closure System Suture Passer
Wallace® Amniocentesis Needle
Wallace® Oocyte Recovery Set
Micropipettes
Stripper Tips---------------------------------First Issued: 2002-08-30

Date: 2020-03-13

Expiry Date: 2024-05-26

Page 3 of 4
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Supplementary Information to CE 69386
Issued To:

NumberClass IsMD 0106
MD 0109
MD 0109
MD 0101
MD 0109
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0106
MD 0109
Class Im
MD 0107
MD 0106

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Device Name

Intended purpose per IFU

Lone Star Retractor Rings
Pasteur Pipettes
Origio Assisted Hatching Pipettes
INCA® Nasal Cannula Set with sterile nasal prongs
Intrauterine Insemination Catheters
Cytology Sampling devices
Endometrial Suction Curette
Hysterosalpingography Catheter
Laparoscopic Smoke Evacuation Systems
Wallach Disposable OS Finders
CSI OS Finders
ABBI (Air Bubble Base Infuser)
EndoSee® Cannula
Sterile Adapter Drapes
Embryo Replacement Catheters-------------------------------

Vaginal Diaphragms Fitting Sets
Milex Pessaries Fitting Kit-----

First Issued: 2002-08-30

Date: 2020-03-13

Expiry Date: 2024-05-26

Page 4 of 4
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Subcontractor:

Service(s) supplied

Cooper Medical SRL
Edificio N° B49, 51 Ave 0
Parque Industrial Zona Franca Coyol
La Garita, Alajuela
Costa Rica

Manufacture

CooperSurgical Distribution B.V
Celsiusweg 355928 PR Venlo
The Netherlands

EU Representative

Drummond Scientific
500 Parkway
Broomall
PA 19008
USA

Crucial Supplier

Emergo Europe
Prinsessegracht 202514 AP The Hague
The Netherlands

EU Representative

Page 1 of 5
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Subcontractor:

Service(s) supplied

Isomedix Operation, Inc.
North Facility
1880 Industrial Drive
Illinois
60048
USA

Gamma Irradiation
Gamma Sterilization

Isomedix Operations, Inc
3459 South Clinton Avenue
South Plainfield
New Jersey
07080
USA

ETO Sterilization

Isomedix Operations, Inc.
435 Whitney Street
Northborough
Massachusetts
01532
USA

Gamma Irradiation
Gamma Sterilization

Page 2 of 5
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Subcontractor:

Service(s) supplied

Isomedix Operations, Inc.
9 Apollo Drive
Whippany
New Jersey
07981
USA

Gamma Irradiation
Gamma Sterilization

Lone Star Medical Products
11211 Cash Road
Stafford
Texas 77477
USA

Manufacture

Origio a/s
Knardrupvej 22760 Måløv
Denmark

EU Representative

Page 3 of 5
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Subcontractor:

Service(s) supplied

Pristech Products Inc.
6952 Fairgrounds Parkway
San Antonio
Texas 78238
USA

Manufacture

Research Instruments Ltd.
Bickland Industrial Park
FalmouthTR11 4TA
United Kingdom

Manufacture

Sterigenics US,LLC
84 Park Road
Queensbury
NY 12804
USA

ETO Sterilization

Page 4 of 5
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Subcontractor:

Service(s) supplied

Sterilization Services of Tennessee, Inc.
2396 Florida Street
MemphisTennessee
38109
USA

ETO Sterilization

UNISIS CORP.
Saitama Plant
2675-1 Nishikata
Koshigaya-shi
Saitama
343-0822
Japan

Crucial Supplier

Page 5 of 5
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate History
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Date

Reference
NumberAction30 August 2002

4316414

Original issue to CooperSurgical Inc for the manufacture of Fetal
Dopplers and Sterile Disposable Uterine Manipulator-Injectors.

04 October 2002

4386116

Amended certificate to add Sterile Colpotomizer Systems to scope.

12 November 2002

4386116

Amended certificate to add the trading name of Ackrad
Laboratories Inc. Also amended scope to include INCA Nasal
Cannulae Set with sterile nasal prongs and Sterile Bronchitrac
Suction Catheters, Esophageal Balloon Catheters, Elliptosphere
Catheters, Tampa Catheters and H/S Catheter sets with Kraton
Balloons.

28 January 2004

4487082

Amended certificate to add the trading name of Prism Healthcare.
Also amended scope to include Gelpacks for heat therapy, sterileand non-sterile Vacuum Assisted Delivery Pumps, sterile Vacuum
Assisted Delivery Extractor Cups and Delivery Kits. Also added a
new subcontractor Pristech Products Inc as manufacture ofgelpacks for heat therapy.

25 February 2004

n/a

Correction of typographical error to address.

Page 1 of 8
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate History
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Date

Reference
NumberAction22 July 2004

4593904

Amended certificate to add the trading name of SAGE In-Vitro
Fertilization Inc. Also, amended scope to include sterile oil andsterile water for Tissue Culture for use in in-vitro fertilization, andSterile Phosphate Buffered Saline (PBS) for use in in-vitro
fertilization Also, modified the Supplementary Information tohighlight Class I Sterile devices.

27 September 2004

4634606

Amended certificate to include Vascular Dopplers within the scope.

30 November 2004

4647383

Amended certificate to include Ophthalmic Cryosurgery Systems
within the scope.

27 April 2005

4657997

Amended certificate to include trading name of Milex andamended scope to include Sterile Curettes and Contraceptive
Diaphragm fitting sets.

19 September 2005

4739488

Extension of scope to include Fiberoptic Cystometry System,
Sterile Fiberoptic Catheter and Cytology Sampling devices.

16 July 2007

7073121

Certificate renewal.
Extension to scope to include Embryo Transfer Catheters.

30 October 2007

7110759

Extension to scope to include Intrauterine Insemination Catheters.

Page 2 of 8
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate History
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Date

Reference
NumberAction23 May 2008

7213846

Extension to scope to include Cryosurgery Systems forgynaecology and dermatology. Also addition of Wallach Surgical
Devices as a trading name.

23 June 2008

7226858

Extension to scope to include CT CloseSure Systems and CT
CloseSure Systems XL.

22 October 2008

7284056

Extension to scope to include endometrial suction curettes.

31 March 2010

7507745

Addition of Lone Star Medical Products as a trading name andaddition of Sterile Surgery Kits, Retractor Kits, Stays, Dilamezinsert
and Sterile Retractors to scope. These were covered by Lone Star
Medical Products BSI CE 553016 issued on 12 October 2009 which
was originally transferred from SGS where Lone Star Medical
Products, Inc. was certified since 4 February 1998. Steris Isomedix
Services, Inc., Coventry, RI - Sterilization was removed and three
new Subcontractors were added: Steris Isomedix, So. Plainfield,
NJ - ETO Sterilization; Leisegang Feinmechanik GmbH, Berlin,
Germany - EU Representative; and Lone Star Medical Products,
Stafford, TX – Manufacture. With this revised certificate, CE
69386, the previous certificate CE 553016 is cancelled.

Page 3 of 8
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate History
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

02 August 2010

Reference
Number754852124 February 2011

7650994

Addition of Laparoscopic Smoke Evacuation Systems to scope.
Addition of significant subcontractor Biotest Laboratories, Inc.

13 February 2012

7752683

Revised format of supplementary pages for clarity.
Addition of vaginal pessaries to scope.
Revision of the following devices to “Those aspects ofAnnex V relating to securing and maintaining sterility in the
manufacture of”.
INCA Nasal Cannulae Set with sterile nasal prongs.
Intrauterine Insemination Catheters.
Revision of the following devices to “Manufacture of”.
Vacuum Assisted Delivery Pumps.
Sterile Elliptosphere Catheters.
Sterile Tampa Catheters.
Sterile H/S Catheters sets with Kraton Balloons.

Date

ActionAddition of Sterigenics US, LLC, 84 Park Road, Glen Falls, New
York, 12804, to the list of significant subcontractors for ETO
sterilization.

Page 4 of 8
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate History
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Date
13 February 2012(continued)

12 June 2012

Reference
Number77526837828419

Action-Removal from certificate scope of.
Oil for Tissue Culture for use in in-vitro fertilization.
Phosphate Buffered Saline (PBS) for use in in-vitro
fertilization.
Water for Tissue Culture for use in in-vitro fertilization.
Addition of Steris Isomedix, Libertyville as a significant
subcontractor.
Removal of Steris Isomedix, Waukegan and Isomedix
Operation Inc as significant subcontractors.
Removal of sterilisation and testing activities for significant
subcontractor Biotest Laboratories.
Clarification of sterilisation method (Gamma Irradiation) for
significant subcontractor Steris Isomedix, Northborough.
Extension to scope of manufacturing to include Trocars, Cannulas
and Trocar/Cannula Kits and Retractors.
Addition of ‘Emergo Europe, Netherlands’ as EU Representative.

Page 5 of 8
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate History
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Date

Reference
NumberAction09 August 2012

7868380

Certificate Renewal.
Removal of ‘Biotest Laboratories, Inc’ as significant subcontractor.

23 July 20138022947

Addition of Vaginal Pessary Fitting Kit.

29 November 2013

8075064

Revision of the following devices to "Those aspects of Annex V
relating to securing and maintaining sterility in the manufactureof".
Elliptosphere catheters, H/S catheter sets with kraton balloons andtampa catheters.
Removal of Sterile Bronchitrac suction catheters from scope.

10 June 2015

7982958

Addition of Limb Plethysmography Systems.

08 September 2015

8413506

Addition of Sterile ABBI.

06 November 2015

8429989

Addition of Endosee Cannulas.

11 March 2016

8485008

Removal of SAGE In-Vitro Fertilization as significant subcontractor.

23 June 2016

8548511Addition of Sterile Os Finder Cervical Dilator, Sterile Disposable
Smoke Evacuation Tubing with Attached Speculum Tubing, andSterile Adapter Drape.

Page 6 of 8
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate History
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Date

Reference
NumberAction07 August 20178695527

Certificate Renewal. Change of address for Emergo Europe.
Change of address for Sterigencics US, LLC. Change of name for
Steris Isomedix Services to Isomedix Operations, Inc.
Removal of Sterile Disposable Smoke Evacuation Tubing with
Attached Speculum Tubing.

26 January 2018

8887080

Addition of IVF Incubators. Addition of Research Instruments as asignificant subcontractor.

23 October 2018

8922778

Addition of Amniocentesis Needles, Embryo Replacement
Catheters, and Oocyte Recovery Needles.
Addition of Cooper Medical SRL, Sterilization Services ofTennessee Inc., and UNISIS CORP as significant subcontractors.

19 February 20199719699

Traceable to NB 0086.

24 January 2020

3143385

Removal of Leisegang Feinmechanik GmbH EU Representative.
Addition of CooperSurgical Distribution B.V. as EU Representative.

Page 7 of 8
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.

EC Certificate - Production Quality Assurance
Certificate History
Certificate No:

CE 69386

Date:

2020-03-13

Issued To:

CooperSurgical Inc.,
also trading as Ackrad Laboratories,
Prism Healthcare, Milex, Medscand,Wallach Surgical Devices,
SAGE In-Vitro Fertilization andLone Star Medical Products
95 Corporate Drive, Trumbull,
Connecticut
06611
USA

Date
Current

Reference
Number9770590

ActionCertificate renewal.
Origio a/s added as EU Representative.
Drummond Scientific added as Crucial Supplier
Isomedix Operations, Inc. (9 Apollo Drive) added as significant
subcontractor for Gamma Irradiation/Gamma Sterilization.
Removal of Sterile Surgery Kits, Dilamezinsert, Limb
Plethysmography Systems, Fiberoptic Cystometry Systems andFiberoptic Catheters from scope.
Embryo Transfer Catheters removed from scope as it is covered by
Embryo replacement catheters.
Added Micropipettes, Stripper Tips and Pasteur/Assisted Hatching
pipettes to scope.
The scope has been reformatted to better reflect the certified
devices and make the expression more understandable.

Page 8 of 8
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.