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Ast-Nf01
EUDAMEDClass C (EU MDR)
Ref ME1001Model Automated Microbiology System AnalyzerRef ME1003
Identity
- Trade Name
- AST-NF01 EUDAMED
- Device Name
- AST-NF01 EUDAMED
- Model / Reference
- Automated Microbiology System Analyzer EUDAMEDME1001 EUDAMEDME1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359521857 EUDAMED06942359535366 EUDAMED
- Basic UDI-DI
- 697015090000193HN EUDAMED
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Category: General-microorganism antimicrobial susceptibility culture medium IVD
Ast-Nf01 by Autobio Diagnostics Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697015090000193HN | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 12b8a50d-69df-4f5d-b2c9-83e6f0224923 61 fields · synced Jul 23, 2026
- EUDAMED 06aabc98-6997-488c-b17d-2a8db04d876a 61 fields · synced May 18, 2026