Certificate of RegistrationQUALITY MANAGEMENT SYSTEM – ISO 13485:2016
CooperSurgical, Inc. also trading as

This is to certify that:Ackrad, Prism, Milex, Medscand, Wallach
Surgical Devices,
SAGE and Lone Star Medical Products
95 Corporate Drive
TrumbullConnecticut
06611
DUNS Number:

USA

80-189-5244

MDSAP 681109

Holds certificate No:

Statement of Conformity: The company listed on this certificate has been audited to and found to conform with thefollowing criteria: ISO 13485:2016 and Australia - Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3
Part 1 (excluding Part 1.6) - Full Quality Assurance Procedure [if design controls are part of the certification]; Brasil - RDC
ANVISA n. 16/2013, RDC ANVISA n. 23/2012, RDC ANVISA n. 67/2009; Canada - Medical Devices Regulations - Part 1SOR 98/282; Japan - MHLW Ministerial Ordinance 169, Article 4 to Article 68, PMD Act; USA - 21 CFR 820, 21 CFR 803, 21
CFR 806, 21 CFR 807 – Subparts A to D

Please see scope page.

For and on behalf of BSI:
Stewart Brain, Head of Compliance & Risk – Medical Devices
Original Registration Date: 2018-12-13

Effective Date: 2018-12-13Expiry date: 2021-12-06
Page: 1 of 3

This certificate remains the property of BSI and shall be returned immediately upon request.
To be read in conjunction with the scope above or the attached appendix.
Managed by: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.

Certificate No:MDSAP 681109

Registered Scope:
The design, development, manufacture and distribution of sterile and non-sterile devices obstetric and gynecology
products, colposcopes, cytology sampling devices, vacuum assist delivery devices, gel packs, cystometry systems,speculums, amniotomes, cryosurgical equipment and probes, electrosurgical generators and electrodes, dopplers,catheters, anoscopes, connectors, operating room instrumentation, fertility devices, critical care respiratory products,
irrigation/drainage devices, bone sonometers, general surgery kits, urological devices and accessories for areas ofurology, radiology, ophthalmology, obstetrics and gynecology, and dermatology.
The manufacture of Pasteur Pipets, and distribution of Sterile Micropipets, Micropipet accessories, and Pasteur Pipets
for In Vitro Fertilization, and stem cell research, cryopreservation devices and other products for the artificial
reproductive technology.

Original Registration Date: 2018-12-13

Effective Date: 2018-12-13

Expiry date: 2021-12-06
Page: 2 of 3

This certificate remains the property of BSI and shall be returned immediately upon request.
To be read in conjunction with the scope above or the attached appendix.
Managed by: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.

Certificate No:

MDSAP 681109

Location

Registered Activities

CooperSurgical, Inc. also trading as

Receiving, Component/material Stock, Inspection, Assembly,Ackrad, Prism, Milex, Medscand, Wallach

testing, labeling, storage, and service & repair. This address is

Surgical Devices,used as legal manufacture address and used on all our labels.

SAGE and Lone Star Medical Products
95 Corporate Drive
TrumbullConnecticut
06611
USA
DUNS Number: 80-189-5244
CooperSurgical, Inc.

Distribution Center, overflow/excess storage of materials to be

50 Corporate Drive

used at 95 Corporate Drive, storage of unused equipment.

Trumbull

Regulatory, Labeling and R & D Engineering offices.

Connecticut
06611
USADUNS Number: 80-189-5244
CooperSurgical, Inc.

Top management, boardroom, finance, HR, IT, Sales &75 Corporate DriveMarketing.

TrumbullConnecticut
06611
USADUNS Number: 80-189-5244

Original Registration Date: 2018-12-13

Effective Date: 2018-12-13

Expiry date: 2021-12-06
Page: 3 of 3

This certificate remains the property of BSI and shall be returned immediately upon request.
To be read in conjunction with the scope above or the attached appendix.
Managed by: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.