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Kitazato OPU Needle

by Kitazato Corporation United States EUDAMED

Ref 338350

EMDN U08020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number458223146OPUL8 Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Kitazato OPU Needle
Model / Reference
338350
Primary DI / UDI-DI
04580303267899
Basic UDI-DI
458223146OPUL8
EMDN Code
U08020201 Single lumen needles and sets/systems for oocyte retrieval
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

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

Other devices from Kitazato Corporation

See all devices from Kitazato Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0cdb7b39-6047-48ab-86dd-cee2e5afbb18 61 fields · synced 23 Oct 2026