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Anti-CCP IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ1410Model AutoLumo analyzerRef CMQ1403Ref CMQ1401Ref CMQ1405
Identity
- Trade Name
- Anti-CCP IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ1410 EUDAMEDCMQ1403 EUDAMEDCMQ1401 EUDAMEDCMQ1405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359515689 EUDAMED06942359543965 EUDAMED06942359515603 EUDAMED06942359543989 EUDAMED
- Basic UDI-DI
- 697015090000116H4 EUDAMED
- EMDN Code
- W01021112 ANTI-CYCLIC CITRULLINATED PEPTIDE 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-CCP 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 | 697015090000116H4 | 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 019b0ea2-8a0d-4cc7-a735-1cda52ed2084 61 fields · synced Jul 22, 2026
- EUDAMED 0be8d385-5526-415d-9241-2f2287030453 61 fields · synced May 18, 2026
- EUDAMED 657f3046-11ae-480e-a805-9fbfa2495dd9 61 fields · synced May 18, 2026
- EUDAMED f277a010-02d3-4dab-97db-076ddf19900e 61 fields · synced May 19, 2026