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RF IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ1203Model AutoLumo analyzerRef CMQ1205Ref CMQ1201
Identity
- Trade Name
- RF IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ1203 EUDAMEDCMQ1205 EUDAMEDCMQ1201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359544467 EUDAMED06942359544481 EUDAMED06942359507691 EUDAMED
- Basic UDI-DI
- 697015090000303H5 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 IgG 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 | 697015090000303H5 | 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 (3)
- EUDAMED 104488f5-e3c6-4c8b-ba4b-101ab3838336 61 fields · synced Jul 26, 2026
- EUDAMED 32353088-ab9a-47cc-b31e-631281260a26 61 fields · synced May 17, 2026
- EUDAMED ba7d98fc-3357-4f2e-9283-19774117380e 61 fields · synced May 19, 2026