Identity
- Trade Name
- GBUK EUDAMED
- Device Name
- Safety Blood Collection Needles EUDAMED
- Model / Reference
- SPN-1 EUDAMEDBCSN-2232 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564463928 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 |
Is this your device? Claim it to add documentation and request validation.
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 d4272e7a-7309-4b43-82d4-b758f65a1262 61 fields · synced May 29, 2026