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Ast-Eb01
EUDAMEDClass C (EU MDR)
Ref ME0902Model Automated Microbiology System AnalyzerRef ME0901
Identity
- Trade Name
- AST-EB01 EUDAMED
- Device Name
- AST-EB01 EUDAMED
- Model / Reference
- Automated Microbiology System Analyzer EUDAMEDME0902 EUDAMEDME0901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359521833 EUDAMED06942359521826 EUDAMED
- Basic UDI-DI
- 697015090000192HL 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
Ast-Eb01 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 | 697015090000192HL | 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 71bdb35c-bf66-4477-8c66-a33a397de600 61 fields · synced Sep 30, 2026
- EUDAMED f5442aae-45ce-41ea-8898-248d30126604 61 fields · synced May 18, 2026