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Sperm Preparation Medium 10700060M

by CooperSurgical, Inc.

Ref 10700060

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 768166 Date8 Jun 2026IssuedStatusActive expires 6 Oct 2029
United StatesGUDID listing GUDID Number00888937029277 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 25 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  • Withdrawn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

Trade Name
Sperm Preparation Medium
Generic Name
IVF medium
Device Name
Sperm Washing media
Model / Reference
10700060 EUDAMED
10700060M GUDID
Primary DI / UDI-DI
00888937029277
Basic UDI-DI
0888937TD09429
Direct Marketing DI
00888937029277
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
10700060
GUDID
10700060M
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K991332)

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