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CryoSperm™

by CooperSurgical, Inc. United States EUDAMED

Ref 11010010Model 11010010M

EMDN U08020501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0888937TD021ZB Basic UDI-DIDate12 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 768161 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    8 Jun 2026
    Expires
    12 Nov 2029
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
11010010M, 11010010
Primary DI / UDI-DI
00888937028140
Basic UDI-DI
0888937TD021ZB
Direct Marketing DI
00888937028140
EMDN Code
U08020501 Materials/solutions for freezing/thawing for assisted reproduction
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000002607
Authorised representative
CooperSurgical Distribution B.V. NL-AR-000000059

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Animal Tissues
  • Incorporates Medicinal Product
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No

Sources (1)

  • EUDAMED 00888937028140|0888937TD021ZB 61 fields · synced 24 Oct 2026