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Gram Negative bacteria ID
EUDAMEDClass C (EU MDR)
Ref ME0602Model Automated Microbiology System AnalyzersRef ME0605Ref ME0603
Identity
- Trade Name
- Gram Negative bacteria ID EUDAMED
- Device Name
- Gram Negative bacteria ID EUDAMED
- Model / Reference
- Automated Microbiology System Analyzers EUDAMEDME0602 EUDAMEDME0605 EUDAMEDME0603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359515078 EUDAMED06942359515108 EUDAMED06942359515085 EUDAMED
- Basic UDI-DI
- 697015090000332HC EUDAMED
- EMDN Code
- W0104080101 GRAM NEGATIVE IDENTIFICATION - 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 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 | 697015090000332HC | 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 d8244ad7-3bca-4009-a3d2-5072a06ba3bb 61 fields · synced Jul 30, 2026
- EUDAMED 61be43af-f51a-476c-9959-7f9557ff55e9 61 fields · synced May 17, 2026
- EUDAMED 4bbefd3f-ea57-4539-beda-03fb6d6810fa 61 fields · synced May 18, 2026