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

CE 80978

Issued To:

Origio Inc.
2400 Hunters Way
Charlottesville
Virginia
22911
USAIn respect of:

The manufacture of sterile micropipettes/stripper tips intended for the preparation,
manipulation and transfer of oocytes, zygotes and embryos during IVF and ICSI procedures.
Those aspects of Annex V relating to securing and maintaining sterility in the manufacture ofPasteur pipettes for transfer of tissue culture media or other non-body liquids during IVF
procedures.

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: 2004-04-06

Date: 2019-04-04

Expiry Date: 2024-04-05

Page 1 of 1
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 80978Date:2019-04-04

Issued To:

Origio Inc.
2400 Hunters Way
Charlottesville
Virginia
22911
USA

Subcontractor:

Service(s) supplied

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

Manufacture

CooperSurgical Inc.
95 Corporate Drive
TrumbullConnecticut
06611
USADry Heat Sterilization
Manufacture
Packaging

Drummond Scientific
500 ParkwayBroomall
PA 19008
USA

Crucial Supplier

Page 1 of 3
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 80978Date:2019-04-04

Issued To:

Origio Inc.
2400 Hunters Way
Charlottesville
Virginia
22911
USA

Subcontractor:

Service(s) supplied

Isomedix Operations, Inc
435 Whitney Street
Northborough
Massachusetts
01532
USA

Gamma Sterilization

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

Gamma Sterilization

Isomedix Operations, Inc.
23 Elizabeth Drive
Chester
New York
10918
USA

Gamma Irradiation

Page 2 of 3
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 80978Date:2019-04-04

Issued To:

Origio Inc.
2400 Hunters Way
Charlottesville
Virginia
22911
USA

Subcontractor:

Service(s) supplied

Origio a/s
Knardrupvej 22760 MåløvDenmark

EU RepresentativePage 3 of 3
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 80978Date:2019-04-04

Issued To:

Origio Inc.
2400 Hunters Way
Charlottesville
Virginia
22911
USA

Date

Reference
Number

06 April 2004

ActionFirst issue.

02 April 2009

7160149

Certificate renewal and Steris Isomedix Sterilization location
change.

21 January 2010

7479496

Company name change from Humagen Fertility Diagnostics to
ORIGIO Humagen Pipets and addition of EU representative.

18 May 2012

7817823

Change of name, addition of adba names and extension to scope
to include plastic tips intended for the manipulation and transferof oocytes and embryos during IVF and ICSI procedures.

7915666

Addition of cryopreservation devices (Cryopette®) to certificate
scope. Addition of Drummond Scientific and Steris Isomedix, NJ
as significant subcontractors.

10 May 2013

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 requiredsurveillance 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 80978Date:2019-04-04

Issued To:

Origio Inc.
2400 Hunters Way
Charlottesville
Virginia
22911
USA

DateReference
NumberAction
Certificate renewal.
The change of scope from ‘The manufacture of cryopreservation
devices (Cryopette®), sterile micropipettes and Pasteur pipettes
for use in vitro fertilization procedures.

14 March 2014

8120225

Those aspects of Annex V relating to securing and maintaining
sterility in the manufacture of plastic tips intended for themanipulation and transfer of oocytes and embryos during IVF andICSI procedures’ to‘The manufacture of sterile cryopreservation devices (Cryopette®)
and sterile micropipettes/stripper tips intended for thepreparation, manipulation and transfer of oocytes, zygotes andembryos during IVF and ICSI procedures.
Those aspects of Annex V relating to securing and maintaining
sterility in the manufacture of Pasteur pipettes for transfer oftissue culture media or other non-body liquids during IVF
procedures’.

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 - Production Quality Assurance
Certificate HistoryCertificate No:

CE 80978Date:2019-04-04

Issued To:

Origio Inc.
2400 Hunters Way
Charlottesville
Virginia
22911
USADateReference
NumberAction

12 July 2014

8192019

Removal of ADBA trading names.
Addition of Steris Isomedix, New York as gamma sterilisation
subcontractor.

04 January 2016

8405607

Addition of CooperSurgical, Inc as manufacturing, packaging, andsterilization subcontractor.

14 August 20188992910Addition of Cooper Medical, SRL as manufacturing subcontractor.
Added sterilization methods utilized to subcontractors.

15 March 20199719742

Traceable to NB 0086.

9685433Certificate renewal.
Removal of Cryopette from scope.
Update of Drummond activity to crucial supplier
Steris subcontractors name change to Isomedix Operations Inc.

Current

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.