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Gram Positive bacteria ID
EUDAMEDClass C (EU MDR)
Ref ME0502Model Automated Microbiology System AnalyzersRef ME0503Ref ME0504
Identity
- Trade Name
- Gram Positive bacteria ID EUDAMED
- Device Name
- Gram Positive bacteria ID EUDAMED
- Model / Reference
- Automated Microbiology System Analyzers EUDAMEDME0502 EUDAMEDME0503 EUDAMEDME0504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359515016 EUDAMED06942359515023 EUDAMED06942359515030 EUDAMED
- Basic UDI-DI
- 697015090000331HA EUDAMED
- EMDN Code
- W0104080103 GRAM POSITIVE 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 Positive 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 | 697015090000331HA | 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 7c77a06e-f7c9-4c9a-a7a1-c74e0bd6993e 61 fields · synced Jul 29, 2026
- EUDAMED bf692049-f963-4d2a-96a8-675c8bcf1dfb 61 fields · synced May 18, 2026
- EUDAMED ec8ec632-e029-4f6c-a427-2103ccbeb020 61 fields · synced May 18, 2026