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Gbsd-50

by Kitazato Corporation

Ref 95721Model Gamete Buffer / SepaSperm® Wash

Gbsd-50 (95721) is a Class III device made by Kitazato Corporation, registered in EUDAMED on 29 Aug 2025 (Basic UDI-DI 458223146GBDGL), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number458223146GBDGL Basic UDI-DI 14582231467317UDI-DIDate29 Aug 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
Gamete Buffer / SepaSperm® Wash, 95721
Primary DI / UDI-DI
14582231467317
Basic UDI-DI
458223146GBDGL
Direct marketing DI
14582231467317
EMDN code
U08020502 Materials/solutions for preparation/handling for assisted reproduction
Device class
Class III
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
JP-MF-000018374
Authorised representative
BIOMEDICAL SUPPLY, S.L. ES-AR-000014358

Similar devices in this category

Other devices filed under MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION.

Other devices from Kitazato Corporation

See all devices from Kitazato Corporation →

Properties

  • Supplied sterile
  • Incorporates a substance derived from human blood or plasma
  • Incorporates a medicinal substance
Other properties (11, all answered No)