Identity
- Trade Name
- GBUK EUDAMED
- Device Name
- Safety Blood Collection Needles EUDAMED
- Model / Reference
- SPN-1 EUDAMEDBCSN-2338 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564463942 EUDAMED
- Basic UDI-DI
- 697156446004802G EUDAMED
- EMDN Code
- A01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Gbuk by Jiangsu Caina Medical Co., Ltd. — 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 | 697156446004802G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a9f6f05c-d985-4600-b5a2-f2826762fc4b 61 fields · synced Oct 6, 2026