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Anti-Jo-1 IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ1903Model AutoLumo analyzerRef CMQ1905Ref CMQ1910
Identity
- Trade Name
- Anti-Jo-1 IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ1903 EUDAMEDCMQ1905 EUDAMEDCMQ1910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359545068 EUDAMED06942359545082 EUDAMED06942359512800 EUDAMED
- Basic UDI-DI
- 697015090000309HH EUDAMED
- EMDN Code
- W0102100108 JO-1 EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMEDItaly 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-Jo-1 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 | 697015090000309HH | 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 29b1f90d-f5e7-43f4-bcab-089d425e37bb 61 fields · synced Jul 18, 2026
- EUDAMED 0ae78e94-e097-4818-9611-e87b7b708ffe 61 fields · synced May 17, 2026
- EUDAMED 5b2abd7b-b664-46e6-ae04-3c60ad3e523a 61 fields · synced May 17, 2026