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Anti-MPO IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ1608Model AutoLumo analyzerRef CMQ1605Ref CMQ1603
Identity
- Trade Name
- Anti-MPO IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ1608 EUDAMEDCMQ1605 EUDAMEDCMQ1603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359513234 EUDAMED06942359545587 EUDAMED06942359545563 EUDAMED
- Basic UDI-DI
- 697015090000314HA EUDAMED
- EMDN Code
- W0102100402 MPO ANCA EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMEDFrance 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
Anti-MPO 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 | 697015090000314HA | 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 c8b85839-1110-4c65-a0ec-e32d40062f46 61 fields · synced Jul 28, 2026
- EUDAMED d3345a19-b1ed-4c54-81f7-b85f39a4639c 61 fields · synced May 17, 2026
- EUDAMED 9bcfa011-5472-4d4a-99fc-bd93181ee43e 61 fields · synced May 19, 2026