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Insulin CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMG0101Model AutoLumo AnalyzerRef CMG0105Ref CMG0103
Identity
- Trade Name
- Insulin CLIA Microparticles EUDAMED
- Device Name
- Insulin CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo Analyzer EUDAMEDCMG0101 EUDAMEDCMG0105 EUDAMEDCMG0103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975577170965 EUDAMED06942359543385 EUDAMED06942359543361 EUDAMED
- Basic UDI-DI
- 697015090000072H9 EUDAMED
- EMDN Code
- W0102060103 INSULIN 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
Insulin CLIA Microparticles 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 | 697015090000072H9 | 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 c316e7d4-6871-446f-87ec-f66177c92124 61 fields · synced Jul 27, 2026
- EUDAMED de8fd804-c9c9-4c22-bbab-983ff4f6df6b 61 fields · synced May 17, 2026
- EUDAMED 79d83244-84c7-40a5-943d-369d5efa2f49 61 fields · synced May 19, 2026