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Gbuk
EUDAMEDClass IIa (EU MDR)
Ref NFC0-D-ARV-EXPModel Dual Lumen with Anti Reflux Valve Neutral Extension Set
Identity
- Trade Name
- GBUK EUDAMED
- Device Name
- Intravenous extension sets w/o accessories EUDAMED
- Model / Reference
- Dual Lumen with Anti Reflux Valve Neutral Extension Set EUDAMEDNFC0-D-ARV-EXP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564461399 EUDAMED
- Basic UDI-DI
- 6971564460030C2P EUDAMED
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 | 6971564460030C2P | 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 ad8edd9b-0f02-49f6-a343-6432d62f2382 61 fields · synced May 29, 2026