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Automated Identification and Susceptibility Testing System
EUDAMEDClass A (EU MDR)
Ref AF-300/AF-360/AF-600/AF-660
Identity
- Device Name
- Automated Identification and Susceptibility Testing System EUDAMED
- Model / Reference
- AF-300/AF-360/AF-600/AF-660 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938010900550 EUDAMED
- Basic UDI-DI
- 69380109005504U EUDAMED
- EMDN Code
- W0203010180 ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Bulgaria 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 Identification and Susceptibility Testing System by Hunan Mindray Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 69380109005504U | 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 30c22e51-933c-43d0-a31f-1064caedb8ad 61 fields · synced Jun 19, 2026