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Anti-Ro-52 IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ0805Model AutoLumo analyzerRef CMQ0803Ref CMQ0810Ref CMQ0808
Identity
- Trade Name
- Anti-Ro-52 IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ0805 EUDAMEDCMQ0803 EUDAMEDCMQ0810 EUDAMEDCMQ0808 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359544788 EUDAMED06942359544764 EUDAMED06942359512534 EUDAMED06942359512510 EUDAMED
- Basic UDI-DI
- 697015090000306HB EUDAMED
- EMDN Code
- W0102100112 SS-A EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMEDTürkiye 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-Ro-52 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 | 697015090000306HB | 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 81c10c24-c507-46dc-90c1-23bc2da0678d 61 fields · synced Jul 17, 2026
- EUDAMED 0946fcfb-bdee-4fd1-8e5a-d780db7e2f3c 61 fields · synced May 17, 2026
- EUDAMED ca026fdb-bb56-4fd9-82cf-4fc855ce6574 61 fields · synced May 18, 2026
- EUDAMED fc4c522b-3f0a-4668-ab70-a67d3598a6b0 61 fields · synced May 18, 2026