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Sperm Preparation Medium

by CooperSurgical, Inc. 3 variants

Ref 10701010

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

CE MDR

Valid until

6 Oct 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 768166 Date8 Jun 2026IssuedStatusActive expires 6 Oct 2029
United StatesGUDID listing GUDID Number60888937029286 UDI-DI Date4 Feb 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 768166 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

0 recalls · FDA

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

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  • Withdrawn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 30 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
IVF medium
Device Name
Sperm Washing media
Model / Reference
10701010 EUDAMED
10701010M GUDID
Primary DI / UDI-DI
60888937029286
Basic UDI-DI
0888937TD09429
Direct Marketing DI
60888937029286
510(k) Number
FDA Product Code
MQL
EMDN Code
U08020502 Materials/solutions for preparation/handling 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
10701010
GUDID
10701010M
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