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Sperm Freezing Medium

by CooperSurgical, Inc.

Ref 10670010Model 11010010M

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

12 Nov 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 768161 Date8 Jun 2026IssuedStatusActive expires 12 Nov 2029
United StatesGUDID listing GUDID Number00888937028157 UDI-DI Date4 Feb 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 768161 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    8 Jun 2026
    Expires
    12 Nov 2029
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
IVF medium
Device Name
CryoSperm™
Model / Reference
11010010M EUDAMED
10670010 EUDAMED
10670010M GUDID
Primary DI / UDI-DI
00888937028157
Basic UDI-DI
0888937TD021ZB
Direct Marketing DI
00888937028157
510(k) Number
FDA Product Code
MQL
EMDN Code
U08020501 Materials/solutions for freezing/thawing for assisted reproduction
GMDN Term
IVF medium
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
884.6180
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
11010010M
10670010
GUDID
10670010M
Device ClassEUDAMED
Class III
GUDID
Class II

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

  • Sterile
  • Animal Tissues
  • Incorporates Medicinal Product
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Single Use: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No