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C-Peptide CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMG0203Model AutoLumo AnalyzerRef CMG0201Ref CMG0205
Identity
- Trade Name
- C-Peptide CLIA Microparticles EUDAMED
- Device Name
- C-Peptide CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo Analyzer EUDAMEDCMG0203 EUDAMEDCMG0201 EUDAMEDCMG0205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359543460 EUDAMED06975577171009 EUDAMED06942359543484 EUDAMED
- Basic UDI-DI
- 697015090000073HB EUDAMED
- EMDN Code
- W0102060101 C-PEPTIDE 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
C-Peptide 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 | 697015090000073HB | 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 1653e478-0c2e-4891-8233-7172935fb212 61 fields · synced Jul 29, 2026
- EUDAMED e1f2e39b-a936-4a6b-9e7f-db92a0b60ed1 61 fields · synced May 18, 2026
- EUDAMED f7851bbe-6bb5-4cdc-b6d1-20896c6aa6ad 61 fields · synced May 18, 2026