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Rubella IgM CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMK0305Model Autolumo analyzerRef CMK0302Ref CMK0303
Identity
- Trade Name
- Rubella IgM CLIA Microparticles EUDAMED
- Model / Reference
- Autolumo analyzer EUDAMEDCMK0305 EUDAMEDCMK0302 EUDAMEDCMK0303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359551960 EUDAMED06970150906849 EUDAMED06942359551946 EUDAMED
- Basic UDI-DI
- 697015090000101GP EUDAMED
- EMDN Code
- W0105040103 RUBELLA VIRUS IGM EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Türkiye EUDAMEDItaly 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
Rubella IgM 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 | 697015090000101GP | 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 a53f85a5-e99e-46c1-8fd5-1c17607cefbb 61 fields · synced Aug 4, 2026
- EUDAMED 99d3cc2b-2a0f-439c-a975-fe743a587b01 61 fields · synced May 17, 2026
- EUDAMED 8810ff6f-0107-42c2-86e7-d85c5999ab39 61 fields · synced May 18, 2026