Identity
- Device Name
- Kitazato OPU Needle EUDAMED
- Model / Reference
- 359352 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580745042924 EUDAMED
- Basic UDI-DI
- 458223146OPUL8 EUDAMED
- EMDN Code
- U08020201 SINGLE 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458223146OPUL8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kitazato Corporation
- EUDAMED SRN
- JP-MF-000018374
- Authorised Representative
- BIOMEDICAL SUPPLY, S.L. ES-AR-000014358
Sources (1)
- EUDAMED 248260a2-b05c-4fce-9954-599949caf9ce 61 fields · synced May 23, 2026