Identity
- Trade Name
- GBUK EUDAMED
- Device Name
- Blood Collection Safety Holder EUDAMED
- Model / Reference
- Holder with Safety Cover EUDAMEDSBCH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971564463994 EUDAMED
- Basic UDI-DI
- 697156446005422D EUDAMED
- EMDN Code
- A01018001 HOLDERS FOR COLLECTION NEEDLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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 I — 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 | 697156446005422D | Class I | 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 f7e83a05-3a25-494f-81be-4783fe122f5c 61 fields · synced May 29, 2026