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Gram Negative bacteria ID/AST
EUDAMEDClass C (EU MDR)
Ref ME0201Model Automated Microbiology System AnalyzersRef ME0202
Identity
- Trade Name
- Gram Negative bacteria ID/AST EUDAMED
- Device Name
- Gram Negative bacteria ID/AST EUDAMED
- Model / Reference
- Automated Microbiology System Analyzers EUDAMEDME0201 EUDAMEDME0202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975577172990 EUDAMED06975577173003 EUDAMED
- Basic UDI-DI
- 697015090000069HL EUDAMED
- EMDN Code
- W0104080109 COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - 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
No
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
Gram Negative bacteria ID/AST 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 | 697015090000069HL | 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 fb435539-6598-43c5-b906-50c111296f35 61 fields · synced Aug 3, 2026
- EUDAMED 7f466304-5214-4ece-b26b-9ac731fd160f 61 fields · synced May 16, 2026