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Auto Blood Culture System
EUDAMEDClass A (EU MDR)
Ref 1503080010Model BT120Ref 1503080007Model BT24
Identity
- Trade Name
- Auto Blood Culture System EUDAMED
- Device Name
- Auto Blood Culture System EUDAMED
- Model / Reference
- BT120 EUDAMED1503080010 EUDAMEDBT24 EUDAMED1503080007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025210603 EUDAMED06971025210542 EUDAMED
- Basic UDI-DI
- 69710252106031116004DC EUDAMED69710252105421116001EJ EUDAMED
- Direct Marketing DI
- 06971025210603 EUDAMED06971025210542 EUDAMED
- EMDN Code
- W02030201 AUTOMATED BLOOD CULTURE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Auto Blood Culture 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 | 69710252106031116004DC | 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 (2)
- EUDAMED 37070780-4ff1-418c-8545-b04b1cc2724c 61 fields · synced Jul 14, 2026
- EUDAMED 40c70fc9-e5bb-41f0-81f4-3c9c2f3aa2ff 61 fields · synced May 17, 2026