EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
Supplementary Information to CE 550877
IssuedTo:
No.
Issued To:

LifeGlobal Group, LLC
CE 550877
a.d.b.a LifeGlobal
LifeGlobal
Group, LLC
393 Soundview
Road
a.d.b.a
LifeGlobal
Guilford, CT 06437
393 USASoundview Road

Guilford, CT 06437
USA

In respect of:

The design, development and manufacture of sterile medical devices for Assisted
Reproductive Technology (ART) procedures;Media with antibiotic and/or protein supplementation for gamete and embryo retrieval,micromanipulation, culture, maintenance, transfer and preservation.
Oil for overlay of ART media during gamete and embryo culture and micromanipulation.
Plastic dishes for gamete and embryo culture and micromanipulation.

on the basis of our examination of the quality assurance system under the requirements of Council Directive
93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For
the placing on the market of class III products an Annex II section 4 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: 2010-04-23
First Issued: 2010-04-23

Date: 2021-03-05
Date: 2021-03-05

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

Page 1 of 2
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 - Full Quality Assurance System
Supplementary Information to CE 550877
Issued To:

LifeGlobal Group, LLC
a.d.b.a LifeGlobal
393 Soundview Road
Guilford, CT 06437
USANumberDevice Name

Intended purpose per IFU

Class III---LG Global---LG Global for Fertilization---

LG Global w/ HEPES---LG Global Collect---

Global Blastocyst Fast Freeze Thawing Kit---

Global total LP---

Global total LP w/HEPES---

Global total LP for Fertilization

---

HSA

See CE 549386

Class IIa
SMD 0109

IVF Media (Oil)---SMD 0109

ART Dishes---

First Issued: 2010-04-23

Date: 2021-03-05

Expiry Date: 2024-05-26

Page 2 of 2
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 - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

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

CE 550877

Date:

2021-03-05

Issued To:

LifeGlobal Group, LLC
a.d.b.a LifeGlobal
393 Soundview Road
Guilford, CT 06437
USA

Subcontractor:

Service(s) supplied

CooperSurgical Canada
24 Norwich St. E
GuelphOntario
N1H 2G6Canada

Manufacture

CooperSurgical, Inc.
95 Corporate Drive
TrumbullConnecticut
06611
USA

Manufacture

CooperSurgical, Inc.
75 Corporate DriveTrumbullConnecticut
06611
USARegulatory Compliance

Page 1 of 4
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 - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

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

CE 550877

Date:

2021-03-05

Issued To:

LifeGlobal Group, LLC
a.d.b.a LifeGlobal
393 Soundview Road
Guilford, CT 06437
USASubcontractor:

Service(s) supplied

CooperSurgical, Inc.
50 Corporate Drive
TrumbullConnecticut
06611
USA

DesignRegulatory ComplianceFagron Belgium NVVenecoweg 20 A
Nazareth
9810
Belgium

Crucial SupplierFertiPro N.V.
Industriepark Noord 328730 Beernem
Belgium

Manufacture

Page 2 of 4
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 - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

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

CE 550877

Date:

2021-03-05

Issued To:

LifeGlobal Group, LLC
a.d.b.a LifeGlobal
393 Soundview Road
Guilford, CT 06437
USASubcontractor:

Service(s) supplied

Fujian Fukang Pharmaceutical Co. ,LtdNo. 6 Gaogang Avenue
Jiangyin Industrial EstateFuqingFuzhou350309 Fujian
China

Medicinal Substances

LifeGlobal Europe
Rue de la Presse 41000 Brussels
Belgium

EU Representative

Octapharma AB
Lars Forssells gata 23
112 75
Stockholm
SwedenCrucial Supplier

Page 3 of 4
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 - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

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

CE 550877

Date:

2021-03-05

Issued To:

LifeGlobal Group, LLC
a.d.b.a LifeGlobal
393 Soundview Road
Guilford, CT 06437
USA

Subcontractor:

Service(s) supplied

Origio a/s
Knardrupvej 22760 MåløvDenmark

DesignThermo Fisher Scientific Inc.
75 Panorama Creek Drive
Rochester
New York 14625-2385
USAManufacture

Page 4 of 4
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 - Full Quality Assurance System
Certificate History
Certificate No:

CE 550877

Date:

2021-03-05

Issued To:

LifeGlobal Group, LLC
a.d.b.a LifeGlobal
393 Soundview Road
Guilford, CT 06437
USA

Date

Reference
NumberAction

23 April 2010

7374717First issue.

02 December 2011

7374715

Extension of Certificate Scope to include devices containing
ancillary antibiotic.

28 May 2013

7804078

Scope extension to include Pioneer Pro-Pump for Aspiration.

01 October 2013

8067356

Change of company name from ‘genX International Inc’ to‘LifeGlobal, LLC, a wholly owned subsidiary of LifeGlobal Group,
LLC.
Change of name of genX Scientific LLC, Ontario to Lifeglobal
LLC.

27 March 2014

8123787

Change of company name from ‘LifeGlobal, LLC, a wholly
owned subsidiary of LifeGlobal Group, LLC' to ‘LifeGlobal Group,
LLC, a.d.b.a LifeGlobal’.

18 November 2014

8239163

Change of EU Representative name 'IVFonline Europe' to'LifeGlobal Europe'. Removal of significant subcontractor'Embryotech Laboratories, Inc.' and 'design' added to theactivities of significant subcontractor 'LifeGlobal, LLC'.

07 April 2015

8292497

Certificate renewal.
Addition of 'Fagron Industry, 8790 Waregem' as significant
subcontractor.

Page 1 of 3
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 - Full Quality Assurance System
Certificate History
Certificate No:

CE 550877

Date:

2021-03-05

Issued To:

LifeGlobal Group, LLC
a.d.b.a LifeGlobal
393 Soundview Road
Guilford, CT 06437
USADateReference
NumberAction

07 June 20178728102

Addition of laboratory dishware and labware to scope.
Addition of Thermo Fisher Scientific as a significant
subcontractor.

29 August 20178789185

Addition of media with protein supplementation.
Addition of Octapharma AB, Sweden as crucial supplier.

19 February 20199719698

Administrative Subcontractor Service wording update from
‘Sterile Manufacture’ to ‘Manufacture’ for Thermo Fisher
Scientific Inc., New York 15625-2385, USA.
Traceable to NB 0086.

09 May 2019

9658394

Addition of subcontractor CooperSurgical, Inc., Trumbull,Connecticut, USA for manufacture of vacuum pumps. Correction
to LifeGlobal Guelph address.

11 December 20193095439

Name change from LifeGlobal, LLC, Guelph, Canada, toCooperSurgical Canada, Guelph, Canada. Removal of design
activity from Guelph Canada facility.

Page 2 of 3
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 - Full Quality Assurance System
Certificate History
Certificate No:

CE 550877

Date:

2021-03-05

Issued To:

LifeGlobal Group, LLC
a.d.b.a LifeGlobal
393 Soundview Road
Guilford, CT 06437
USADateReference
NumberAction

11 May 20209770430

Certificate renewal.
Name and address updated for crucial supplier Fagron Industry.
Address updated for crucial supplier Octapharma AB.
Fujian Fukang Pharmaceutical Co.,Ltd added as significant
subcontractor (Medicinal substances) as the manufacturer ofgentamicin sulphate
Removal of vacuum pumps for aspiration (Pioneer Pro Pump)from scope.
Removal of class Is dishware and labware from scope.
Removal of media without antibiotic and protein
supplementation from scope.
Added plastic dishes for gamete and embryo culture or
micromanipulation to scope.
The scope has been reformatted to better reflect the certified
devices.

Current

3389475

Addition of CooperSurgical, Inc. (50 Corporate Drive),
CooperSurgical, Inc. (75 Corporate Drive) and Origio a/s as
significant subcontractors.

Page 3 of 3
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.