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Anti-CL IgA CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMQ3708Model AutoLumo analyzerRef CMQ3703Ref CMQ3710Ref CMQ3705
Identity
- Trade Name
- Anti-CL IgA CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ3708 EUDAMEDCMQ3703 EUDAMEDCMQ3710 EUDAMEDCMQ3705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359514958 EUDAMED06942359547161 EUDAMED06942359514972 EUDAMED06942359547185 EUDAMED
- Basic UDI-DI
- 697015090000330H8 EUDAMED
- EMDN Code
- W0102100501 ANTI-CARDIOLIPIN ANTIBODIES EUDAMED
Classification
- Device Class
- Class C 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
Anti-CL IgA 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 | 697015090000330H8 | 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 (4)
- EUDAMED 7bb55ddc-546d-4f46-8936-aa2d148b1d8c 61 fields · synced Jul 19, 2026
- EUDAMED 1b4d4b50-3267-4229-9a94-89059dfc0de2 61 fields · synced May 17, 2026
- EUDAMED 6d66ceeb-e9b7-44c8-bd36-06e874179531 61 fields · synced May 17, 2026
- EUDAMED 45aa4f07-7229-40bf-b174-dc992125e619 61 fields · synced May 18, 2026