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Biological Isolation Chamber
EUDAMEDClass I (EU MDR)
Ref BFG-VIModel BFG-IV, BFG-VI
Identity
- Trade Name
- Biological Isolation Chamber EUDAMED
- Device Name
- Biological Isolation Chamber EUDAMED
- Model / Reference
- BFG-IV, BFG-VI EUDAMEDBFG-VI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974738682514 EUDAMED
- Basic UDI-DI
- 697473868XBX008Y5 EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Biological Isolation Chamber by Jinan Biobase Biotech 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 | 697473868XBX008Y5 | Class I | Active |
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Manufacturer
- Manufacturer
- Jinan Biobase Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000027133
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 08d3925f-b462-43b3-b693-65587f61f04f 61 fields · synced Jun 18, 2026