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RF IgA CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ1303Model AutoLumo analyzerRef CMQ1301Ref CMQ1310
Identity
- Trade Name
- RF IgA CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ1303 EUDAMEDCMQ1301 EUDAMEDCMQ1310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359544566 EUDAMED06942359507745 EUDAMED06942359512350 EUDAMED
- Basic UDI-DI
- 697015090000304H7 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 IgA 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 | 697015090000304H7 | 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 2d1ad83b-523c-4c97-99c4-d91a57f5db63 61 fields · synced Jul 17, 2026
- EUDAMED dfb01a90-37a4-4c8e-a482-376613749356 61 fields · synced May 18, 2026
- EUDAMED 63df21d9-1ef5-4fc7-b11b-1b7999ae0248 61 fields · synced May 19, 2026