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Anti-β2-GP1 CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMQ2905Model AutoLumo analyzerRef CMQ2908Ref CMQ2903
Identity
- Trade Name
- Anti-β2-GP1 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ2905 EUDAMEDCMQ2908 EUDAMEDCMQ2903 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359546485 EUDAMED06942359514002 EUDAMED06942359546461 EUDAMED
- Basic UDI-DI
- 697015090000321H7 EUDAMED
- EMDN Code
- W0102100503 ANTI-B2-GLYCOPROTEIN I 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-β2-GP1 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 | 697015090000321H7 | 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 (3)
- EUDAMED 1aebdbf2-5219-4894-be26-90b22954c5ab 61 fields · synced Jul 15, 2026
- EUDAMED 85ea0643-2488-4352-8e41-bd91a96fc446 61 fields · synced May 17, 2026
- EUDAMED 635524ca-e59e-4829-a9e7-4c1c4e8ced48 61 fields · synced May 18, 2026