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ProGRP CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB1905Model AutoLumo analyzerRef CMB1903Ref CMB1910
Identity
- Trade Name
- ProGRP CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB1905 EUDAMEDCMB1903 EUDAMEDCMB1910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359550413 EUDAMED06942359550390 EUDAMED06942359509046 EUDAMED
- Basic UDI-DI
- 697015090000228HG EUDAMED
- EMDN Code
- W0102030121 PRO-GASTRIN-RELEASING PEPTIDE EUDAMED
Classification
- Device Class
- Class C 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
EUDAMEDEUDAMED
ProGRP CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class C — 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 | 697015090000228HG | Class C | 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 (3)
- EUDAMED 355ce6b1-2a50-4670-a6b9-2258b9d51a3b 61 fields · synced Aug 2, 2026
- EUDAMED d0a8928a-1890-4991-880e-ac7923e0a171 61 fields · synced May 16, 2026
- EUDAMED 1e6a1385-ee13-4651-bcdb-019ab2a589b3 61 fields · synced May 19, 2026