Identity
- Trade Name
- Kitazato OPU Needle with Connection Tube, Type2-v16 FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- Kitazato OPU Needle EUDAMED21G300mm, L Stopper FDA UDI
- Model / Reference
- 321300 EUDAMED321002 Type2-v16 FDA UDI
- Description
- 21G300mm, L Stopper FDA UDI
Identifiers
- Catalog Number
- 321002 FDA UDI
- Primary DI / UDI-DI
- 04580303269862 EUDAMEDFDA UDI
- Basic UDI-DI
- 458223146OPUL8 EUDAMED
- 510(k) Number
- K162881 FDA UDI
- FDA Product Code
- MQE FDA UDI
- EMDN Code
- U08020201 SINGLE LUMEN NEEDLES AND SETS/SYSTEMS FOR OOCYTE RETRIEVAL EUDAMED
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6100 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Kitazato OPU Needle by Kitazato Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162881 | Class IIa | Active |
| 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 (3)
- EUDAMED 2c3b2745-3ca0-486c-ba08-f3dc6ee5c85d 61 fields · synced Jul 10, 2026
- FDA UDI 671d35da-4be6-4e82-9540-30c87ea8aa17 35 fields · synced May 30, 2026
- FDA 510(k) K162881 1 fields · synced May 18, 2026