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Anti-SS-A/Ro IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ0710Model AutoLumo analyzerRef CMQ0708Ref CMQ0703Ref CMQ0705
Identity
- Trade Name
- Anti-SS-A/Ro IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ0710 EUDAMEDCMQ0708 EUDAMEDCMQ0703 EUDAMEDCMQ0705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359512442 EUDAMED06942359512428 EUDAMED06942359544665 EUDAMED06942359544689 EUDAMED
- Basic UDI-DI
- 697015090000305H9 EUDAMED
- EMDN Code
- W0102100112 SS-A EUDAMED
Classification
- Device Class
- Class B 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-SS-A/Ro 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 | 697015090000305H9 | 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 (4)
- EUDAMED 75f5d5a9-c259-4645-b551-61eb9b638b90 61 fields · synced Aug 1, 2026
- EUDAMED 04995642-f7a1-473f-aa91-96eaf354c2f5 61 fields · synced May 17, 2026
- EUDAMED 9ad0314e-2782-4edc-87a9-280a9ccf287b 61 fields · synced May 18, 2026
- EUDAMED 678c40fc-a2e7-4ffb-b3aa-dda717e840e5 61 fields · synced May 19, 2026