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Automated Blood Culture System
EUDAMEDClass A (EU MDR)
Ref BK-BC64Model BK-BC series
Identity
- Trade Name
- Automated Blood Culture System EUDAMED
- Device Name
- Automated Blood Culture System EUDAMED
- Model / Reference
- BK-BC series EUDAMEDBK-BC64 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936895302919 EUDAMED
- Basic UDI-DI
- 69368953029BC***5M EUDAMED
- EMDN Code
- W02030201 AUTOMATED BLOOD CULTURE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Automated Blood Culture System by Biobase Biodustry(Shandong) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69368953029BC***5M | Class A | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 29f8e581-b2b6-4ab0-8b25-9cffe2b2fb78 61 fields · synced Oct 6, 2026