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Vitrification Media

by CooperSurgical, Inc.

Ref 12295002

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

CE MDR

Valid until

24 Sep 2029

CE MDR certificate

FDA recalls

None ongoing

1 closed

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 768181 Date17 Sep 2026IssuedStatusActive expires 24 Sep 2029
United StatesGUDID listing GUDID Number60888937029194 UDI-DI Date5 Feb 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 768181 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    17 Sep 2026
    Expires
    24 Sep 2029
    Reason
    Add device or group

Recalls

1 recall · FDA

    • Terminated Z-0100-2021 FDA Class II initiated 8 Sep 2020

    There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

Coverage

2 jurisdictions

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  • Withdrawn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

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 31 Dec 2025
  • Belgium since 31 Dec 2025
  • Bulgaria since 31 Dec 2025
  • Croatia since 31 Dec 2025
  • Cyprus since 31 Dec 2025
  • Czechia since 31 Dec 2025
  • Denmark since 31 Dec 2025
  • Estonia since 31 Dec 2025
  • Finland since 31 Dec 2025
  • France since 31 Dec 2025
  • Germany since 31 Dec 2025
  • Greece since 31 Dec 2025
  • Hungary since 31 Dec 2025
  • Iceland since 31 Dec 2025
  • Ireland since 31 Dec 2025
  • Italy since 31 Dec 2025
  • Latvia since 31 Dec 2025
  • Liechtenstein since 31 Dec 2025
  • Lithuania since 31 Dec 2025
  • Luxembourg since 31 Dec 2025
  • Malta since 31 Dec 2025
  • Netherlands since 31 Dec 2025
  • Northern Ireland since 31 Dec 2025
  • Norway since 31 Dec 2025
  • Poland since 31 Dec 2025
  • Portugal since 31 Dec 2025
  • Romania since 31 Dec 2025
  • Slovakia since 31 Dec 2025
  • Slovenia since 31 Dec 2025
  • Spain since 31 Dec 2025
  • Sweden since 31 Dec 2025
  • Türkiye since 31 Dec 2025

Last checked 27 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Vitrification Media EUDAMED
MC Vitrification Cooling GUDID
Generic Name
IVF medium kit
Model / Reference
12295002 EUDAMED
12284001M GUDID
Primary DI / UDI-DI
60888937029194
Basic UDI-DI
0888937TD09225
Direct Marketing DI
60888937029194
510(k) Number
FDA Product Code
MQL
EMDN Code
U08020501 Materials/solutions for freezing/thawing for assisted reproduction
GMDN Term
IVF medium kit
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
12295002
GUDID
12284001M
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
  • Single Use
  • Human-derived
  • Incorporates Medicinal Product
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No