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Fertilization Media

by CooperSurgical, Inc. 5 variants

Ref H5TF-050

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

CE MDR

Valid until

6 Oct 2029

CE MDR certificate

FDA recalls

2 ongoing

This device is named in the recall

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 768172 Date8 Jun 2026IssuedStatusActive expires 6 Oct 2029
United StatesGUDID listing GUDID Number00888937028515 UDI-DI Date11 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 768172 Active Supplemented

    Technical documentation EU MDR

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

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1089-2024 FDA Class II initiated 20 Dec 2023

    The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.

    • Ongoing Z-1348-2023 FDA Class II initiated 13 Feb 2023

    It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.

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  • Withdrawn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 23 Mar 2026
  • Belgium since 23 Mar 2026
  • Bulgaria since 23 Mar 2026
  • Croatia since 23 Mar 2026
  • Cyprus since 23 Mar 2026
  • Czechia since 23 Mar 2026
  • Denmark since 23 Mar 2026
  • Estonia since 23 Mar 2026
  • Finland since 23 Mar 2026
  • France since 23 Mar 2026
  • Germany since 23 Mar 2026
  • Greece since 23 Mar 2026
  • Hungary since 23 Mar 2026
  • Iceland since 23 Mar 2026
  • Ireland since 23 Mar 2026
  • Italy since 23 Mar 2026
  • Latvia since 23 Mar 2026
  • Liechtenstein since 23 Mar 2026
  • Lithuania since 23 Mar 2026
  • Luxembourg since 23 Mar 2026
  • Malta since 23 Mar 2026
  • Netherlands since 23 Mar 2026
  • Northern Ireland since 23 Mar 2026
  • Norway since 23 Mar 2026
  • Poland since 23 Mar 2026
  • Portugal since 23 Mar 2026
  • Romania since 23 Mar 2026
  • Slovakia since 23 Mar 2026
  • Slovenia since 23 Mar 2026
  • Spain since 23 Mar 2026
  • Sweden since 23 Mar 2026
  • Türkiye since 23 Mar 2026

Last checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Fertilization Media EUDAMED
LifeGlobal® Media GUDID
Generic Name
IVF medium
Model / Ref / Catalog
H5TF-050 EUDAMED
H5TF-050M GUDID
Primary DI / UDI-DI
00888937028515
Basic UDI-DI
0888937TD037ZS
Direct Marketing DI
00888937028515
510(k) Number
FDA Product Code
MQL
EMDN Code
U08020503 Materials/culture media 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
H5TF-050
GUDID
H5TF-050M
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
  • Human-derived
  • Animal Tissues
  • Incorporates Medicinal Product
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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