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Kitazato OPU Needle

EUDAMED

Class IIa (EU MDR)

Ref 350350Ref 367350Ref 336350Ref 359354Ref 337350Ref 347275Ref 357353Ref 377350Ref 350352Ref 310001Ref 351354Ref 358354Ref 357354Ref 319001

by Kitazato Corporation

Identity

Device Name
Kitazato OPU Needle EUDAMED
Model / Reference
350350 EUDAMED
367350 EUDAMED
336350 EUDAMED
359354 EUDAMED
337350 EUDAMED
347275 EUDAMED
357353 EUDAMED
377350 EUDAMED
350352 EUDAMED
310001 EUDAMED
351354 EUDAMED
358354 EUDAMED
357354 EUDAMED
319001 EUDAMED

Identifiers

Primary DI / UDI-DI
04580745042962 EUDAMED
04580303266496 EUDAMED
04580303266410 EUDAMED
04580303262924 EUDAMED
04580303266427 EUDAMED
04580303260906 EUDAMED
04580303266533 EUDAMED
04580303267332 EUDAMED
04580745042948 EUDAMED
04580303265086 EUDAMED
04580745042979 EUDAMED
04580745041408 EUDAMED
04580303261934 EUDAMED
04580303264690 EUDAMED
Basic UDI-DI
458223146OPUL8 EUDAMED
EMDN Code
U08020201 SINGLE LUMEN NEEDLES AND SETS/SYSTEMS FOR OOCYTE RETRIEVAL EUDAMED
U08020202 DOUBLE LUMEN NEEDLES AND SETS/SYSTEMS FOR OOCYTE RETRIEVAL EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Kitazato OPU Needle by Kitazato Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

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

Sources (14)

  • EUDAMED da3d26e0-e339-433b-aab0-89c5cc908482 61 fields · synced Sep 17, 2026
  • EUDAMED 38243dbf-249a-454c-9665-38e7db6ab776 61 fields · synced May 16, 2026
  • EUDAMED 41d0f562-46f8-43cb-b943-e7053bc7976c 61 fields · synced May 17, 2026
  • EUDAMED eb0243c3-7c48-44ac-8fbf-81acb91df471 61 fields · synced May 17, 2026
  • EUDAMED 1dc2fdb7-b440-4e28-934b-944971e77fc3 61 fields · synced May 17, 2026
  • EUDAMED 453fb01f-845a-4d49-bba8-03c5f3c83c35 61 fields · synced May 18, 2026
  • EUDAMED 47cadf1c-49f7-4522-84c0-879df308a5fa 61 fields · synced May 18, 2026
  • EUDAMED 42439f6c-8261-47df-ba10-2e5920f73558 61 fields · synced May 18, 2026
  • EUDAMED 0584dc1b-32d2-4224-8d3e-3e60656ee073 61 fields · synced May 18, 2026
  • EUDAMED 14647691-d2f4-46ba-ba0f-06d498fdbe8c 61 fields · synced May 18, 2026
  • EUDAMED 0371770f-97d4-45fd-afcd-4b08e2957777 61 fields · synced Jul 9, 2026
  • EUDAMED 7840cd5b-3ccb-4b34-9cd2-9a9781cb131c 61 fields · synced Jul 28, 2026
  • EUDAMED 81f8874f-6637-4a91-a9d0-92f93579ae7b 61 fields · synced Jul 31, 2026
  • EUDAMED 955dbb49-276e-4df3-8f80-8e16b103b806 61 fields · synced Aug 4, 2026