Certificate of RegistrationQUALITY MANAGEMENT SYSTEM - ISO 13485:2016
This is to certify that:

CooperSurgical, Inc. also trading as
Ackrad, Prism, Milex, Medscand, Wallach
Surgical Devices,
SAGE and Lone Star Medical Products
95 Corporate Drive
TrumbullConnecticut
06611
USA

Holds Certificate No:

FM 72267

and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for thefollowing scope:

Please see scope page.

For and on behalf of BSI:
Stewart Brain, Head of Compliance & Risk - Medical Devices
Original Registration Date: 2002-12-13

Effective Date: 2018-12-13

Latest Revision Date: 2018-12-13

Expiry Date: 2021-12-06
Page: 1 of 3

This certificate remains the property of BSI and shall be returned immediately upon request.
An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory
To be read in conjunction with the scope above or the attached appendix.
Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.

Certificate No:

FM 72267

Registered Scope:
The design, development, manufacture and distribution of sterile and non-sterile devices including
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, needles, anoscopes, connectors, operating
room instrumentation, assisted reproductive media formulations, fertility devices, IVF and ART products
and laboratory instruments, critical care respiratory products, irrigation/drainage devices, bonesonometers, general surgery kits, urological devices and accessories, for areas of urology, radiology,ophthalmology, obstetrics and gynecology, In Vitro Fertilization [IVF], Assisted Reproductive Technology[ART] and dermatology.
The manufacture of Pasteur Pipets and the distribution of Sterile Micropipets, Micropipet accessories, andPasteur Pipets for In Vitro Fertilization, and stem cell research, cryopreservation devices and otherproducts for the artificial reproductive technology [ART] market. The distribution of Semen Analysis Kits
and Counting Chambers.

Original Registration Date: 2002-12-13

Effective Date: 2018-12-13

Latest Revision Date: 2018-12-13Expiry Date: 2021-12-06
Page: 2 of 3

This certificate remains the property of BSI and shall be returned immediately upon request.
An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory
To be read in conjunction with the scope above or the attached appendix.
Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.

Certificate No:

FM 72267

Location

Registered Activities

CooperSurgical, Inc. also trading as
Ackrad, Prism, Milex, Medscand, Wallach
Surgical Devices,
SAGE and Lone Star Medical Products
95 Corporate Drive
TrumbullConnecticut
06611
USAReceiving, Component/material Stock, Inspection, Assembly,testing, labeling, storage, and service & repair. This address
is used as legal manufacture address and used on all ourlabels.

CooperSurgical, Inc.
50 Corporate Drive
TrumbullConnecticut
06611
USA

Distribution Center, overflow/excess storage of materials to
be used at 95 Corporate Drive, storage of unused equipment.
Regulatory, Lableing and R & D Engineering offices.

CooperSurgical, Inc.
75 Corporate Drive
TrumbullConnecticut
06611USATop management, boardroom, finance, HR, IT, Sales &Marketing.

Lone Star Medical Products
11211 Cash Road
Stafford
Texas77477
USA

Design and manufacture of sterile and non-sterile generalsurgery kits, devices and accessories, urological devices,
Trocars, Cannulas and Trocar / Cannula kits.

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

Manufacture of catheters, needles and micro pipettes.

Original Registration Date: 2002-12-13

Effective Date: 2018-12-13

Latest Revision Date: 2018-12-13

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

This certificate remains the property of BSI and shall be returned immediately upon request.
An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory
To be read in conjunction with the scope above or the attached appendix.
Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.