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G-17 CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMB2103Model AutoLumo analyzerRef CMB2105
Identity
- Trade Name
- G-17 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB2103 EUDAMEDCMB2105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359550192 EUDAMED06942359550215 EUDAMED
- Basic UDI-DI
- 697015090000231H5 EUDAMED
- EMDN Code
- W0102069001 GASTRIN 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
Yes
EUDAMED
G-17 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 | 697015090000231H5 | 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 9eb9683e-093d-410b-8f6a-e2745b13466a 61 fields · synced Jul 26, 2026
- EUDAMED d3dd4ed9-424f-47dc-8195-c0e4951223f0 61 fields · synced May 19, 2026