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Automated Blood Culture Systems
EUDAMEDClass A (EU MDR)
Ref TDR-X360Model TDR-X060\TDR-X120\TDR-X120II\TDR-X240\TDR-X360
Identity
- Device Name
- Automated Blood Culture Systems EUDAMED
- Model / Reference
- TDR-X060\TDR-X120\TDR-X120II\TDR-X240\TDR-X360 EUDAMEDTDR-X360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06983010900628 EUDAMED
- Basic UDI-DI
- 69380109002914T EUDAMED
- EMDN Code
- W02030201 AUTOMATED BLOOD CULTURE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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
Automated Blood Culture Systems by Hunan Mindray Medical Technology Co., Ltd. — Class A — CE/MDR — 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 | 69380109002914T | Class A | Active |
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Manufacturer
- Manufacturer
- Hunan Mindray Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022479
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 14218007-88ae-4757-83e8-9072a3312dbe 61 fields · synced Oct 7, 2026