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Anti-PR3 IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ1508Model AutoLumo analyzerRef CMQ1510
Identity
- Trade Name
- Anti-PR3 IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ1508 EUDAMEDCMQ1510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359513142 EUDAMED06942359513166 EUDAMED
- Basic UDI-DI
- 697015090000313H8 EUDAMED
- EMDN Code
- W0102100403 PR3 ANCA 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Anti-PR3 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 | 697015090000313H8 | 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 (2)
- EUDAMED bf366b96-bc2e-4c50-8da9-a04a2e4aa3cb 61 fields · synced Sep 17, 2026
- EUDAMED f5b01145-2798-416c-8de7-33e65d5253b5 61 fields · synced May 18, 2026