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  • MD Atlas
  • Documents

CooperSurgical, Inc.

Certificate MDR 768166

Rev. R001Supplemented
Valid until
Oct 6, 2029

Certificate MDR 768166 is a valid Technical documentation issued to CooperSurgical, Inc. and registered in EUDAMED. Valid until October 6, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number
MDR 768166
Certificate type
Technical documentation
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
2797MDR 768166R001

Validity

Issued
Jun 8, 2026
Valid from
Jun 8, 2026
Valid until
Oct 6, 2029

Notified body

Notified body
BSI Group The Netherlands B.V.
Notified body SRN
2797
Notified body country
Netherlands

Characteristics

Sterile
—
Human tissues
—
Animal tissues
—
In vitro diagnostics
—
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
Intended medical purpose
—
SPP applicable
—
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

Status changes

  • Supplemented

Supersedes

  • MDR 768166AmendedNov 19, 2025 → Oct 6, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Unspecified1

1 scope

  • Sperm Washing media
    0888937TD09429

Documents

LanguagesEN

Manufacturer

Manufacturer
CooperSurgical, Inc.
Manufacturer SRN
US-MF-000002607
Manufacturer country
United States

Covered devices

  • Sperm Washing mediaClass III
    0888937TD09429

Linked SSCPs

  • SSCP SSC0094