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ORIGIO Sperm Wash 84051010M

by CooperSurgical, Inc.

Ref 84051010

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

CE MDR

Valid until

6 Oct 2029

CE MDR certificate

FDA recalls

3 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 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 Number60888937029323 UDI-DI Date5 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

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-3298-2024 FDA Class II initiated 16 Feb 2024
    • Ongoing Z-3297-2024 FDA Class II initiated 16 Feb 2024
    • Ongoing Z-3296-2024 FDA Class II initiated 16 Feb 2024

    Low concentration of sodium pyruvate in the wash could compromise gamete development

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  • Withdrawn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
ORIGIO® Sperm Wash EUDAMED
ORIGIO Sperm Wash GUDID
Generic Name
IVF medium
Device Name
Sperm Washing media
Model / Reference
84051010 EUDAMED
84051010M GUDID
Primary DI / UDI-DI
60888937029323
Basic UDI-DI
0888937TD09429
Direct Marketing DI
60888937029323
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
84051010
GUDID
84051010M
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K153267)

Show all (12)

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