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Anti-CL IgM CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMQ3603Model AutoLumo analyzerRef CMQ3610Ref CMQ3608Ref CMQ3605
Identity
- Trade Name
- Anti-CL IgM CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ3603 EUDAMEDCMQ3610 EUDAMEDCMQ3608 EUDAMEDCMQ3605 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359547062 EUDAMED06942359514866 EUDAMED06942359514842 EUDAMED06942359547086 EUDAMED
- Basic UDI-DI
- 697015090000329HP 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 IgM 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 | 697015090000329HP | 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 24cda34e-f9ed-4c15-a4ae-72628ec13f45 61 fields · synced Jul 18, 2026
- EUDAMED 86a4ffb5-cdaa-40af-a97b-e5835d15507a 61 fields · synced May 18, 2026
- EUDAMED bbd6b198-44e4-40c8-a40f-4a751e2130fb 61 fields · synced May 18, 2026
- EUDAMED f769b5fa-b6a7-4331-82f6-34743368a2b7 61 fields · synced May 19, 2026