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Ast-St01
EUDAMEDClass C (EU MDR)
Ref ME1201Model Automated Microbiology System AnalyzerRef ME1203Ref ME1202
Identity
- Trade Name
- AST-ST01 EUDAMED
- Device Name
- AST-ST01 EUDAMED
- Model / Reference
- Automated Microbiology System Analyzer EUDAMEDME1201 EUDAMEDME1203 EUDAMEDME1202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359535403 EUDAMED06942359535427 EUDAMED06942359535410 EUDAMED
- Basic UDI-DI
- 697015090000195HS EUDAMED
- EMDN Code
- W0104080108 GRAM POSITIVE 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
Ast-St01 by Autobio Diagnostics Co., Ltd. — Class C — 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 | 697015090000195HS | 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 (3)
- EUDAMED 548572ec-9f19-4285-a085-e906b3f1ca7c 61 fields · synced Aug 3, 2026
- EUDAMED 63fb8ddf-4f09-44b5-bd1f-28a81227e065 61 fields · synced May 17, 2026
- EUDAMED eb8fb154-5893-416f-9bbe-48eb669c7fcf 61 fields · synced May 18, 2026