Identity
- Trade Name
- Peds Aerobic Culture Vials EUDAMED
- Device Name
- Peds Aerobic Culture Vials EUDAMED
- Model / Reference
- PC EUDAMED105-053880-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938010902783 EUDAMED06938010902547 EUDAMED
- Basic UDI-DI
- 69380109025475M 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
EUDAMEDEUDAMED
Peds 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 | 69380109025475M | 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 (2)
- EUDAMED 39d92b9d-70f1-4634-b99c-0604b419e70a 61 fields · synced Oct 6, 2026
- EUDAMED f4553d1b-3dd6-487d-bed4-d88a7d5560db 61 fields · synced May 17, 2026