Identity
- Trade Name
- Aerobic Culture Vials EUDAMED
- Device Name
- Aerobic Culture Vials EUDAMED
- Model / Reference
- AC EUDAMED105-053878-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938010902769 EUDAMED
- Basic UDI-DI
- 693801090252357 EUDAMED
- EMDN Code
- W0104010504 BOTTLES FOR AUTOMATED BLOOD CULTURE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Aerobic Culture Vials by Hunan Mindray Medical Technology 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 | 693801090252357 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
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 c6afca0c-cc45-40ed-9442-ed36f57d9afb 61 fields · synced Oct 6, 2026