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Fully auto blood culture analysis system
EUDAMEDClass A (EU MDR)
Ref 1503090003Model BT Station 3020
Identity
- Trade Name
- Fully auto blood culture analysis system EUDAMED
- Device Name
- Fully Auto Blood Culture Analysis System EUDAMED
- Model / Reference
- BT Station 3020 EUDAMED1503090003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025211839 EUDAMED
- Basic UDI-DI
- 69710252118390909001QP EUDAMED
- Direct Marketing DI
- 06971025211839 EUDAMED
- EMDN Code
- W02030201 AUTOMATED BLOOD CULTURE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Fully auto blood culture analysis system by Zhuhai DL Biotech 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 | 69710252118390909001QP | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai DL Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000036485
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f1b72ba9-000b-4bae-9b30-b5ad89e70ad3 61 fields · synced Jun 18, 2026