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CMV IgG CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMK0702Model Autolumo analyzerRef CMK0705
Identity
- Trade Name
- CMV IgG CLIA Microparticles EUDAMED
- Model / Reference
- Autolumo analyzer EUDAMEDCMK0702 EUDAMEDCMK0705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150908867 EUDAMED06942359552110 EUDAMED
- Basic UDI-DI
- 697015090000105GX EUDAMED
- EMDN Code
- W0105040203 CMV IGG EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
CMV IgG 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 | 697015090000105GX | 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 8a23059f-35bc-4e35-a370-e3ca678bc661 61 fields · synced Sep 18, 2026
- EUDAMED 310104da-aeaa-48a5-a088-ccb4dec149f3 61 fields · synced May 17, 2026