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Anti-GBM IgG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ1705Model AutoLumo analyzerRef CMQ1708
Identity
- Trade Name
- Anti-GBM IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMQ1705 EUDAMEDCMQ1708 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359545686 EUDAMED06942359513326 EUDAMED
- Basic UDI-DI
- 697015090000315HC EUDAMED
- EMDN Code
- W0102109014 ANTIBODIES TO GLOMERULAR BASAL MEMBRANE 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-GBM 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 | 697015090000315HC | 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 528a8068-6c5e-47e3-801a-22f1a71ddb94 61 fields · synced Jul 11, 2026
- EUDAMED e2081885-8731-437a-a461-88da89714cd3 61 fields · synced May 17, 2026