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RF IgM CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ1105Model AutoLumo analyzerRef CMQ1103Ref CMQ1110Ref CMQ1101
Identity
- Trade Name
- RF IgM CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ1105 EUDAMEDCMQ1103 EUDAMEDCMQ1110 EUDAMEDCMQ1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359544382 EUDAMED06942359544368 EUDAMED06942359512176 EUDAMED06942359515528 EUDAMED
- Basic UDI-DI
- 697015090000302H3 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
RF IgM CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class B — 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 | 697015090000302H3 | Class B | 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 (4)
- EUDAMED b0930e50-5b7d-4c76-8b3f-18b91a7b18f9 61 fields · synced Jul 11, 2026
- EUDAMED 6653a60a-5d27-41d5-a374-5f2d5085e411 61 fields · synced May 17, 2026
- EUDAMED 9466ee7b-7c25-4a48-9e5e-95abc9dccf08 61 fields · synced May 17, 2026
- EUDAMED 1641d70c-99b1-4504-912e-46ba2f533e44 61 fields · synced May 19, 2026