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hs-CRP CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMR0105Model AutoLumo analyzerRef CMR0102
Identity
- Trade Name
- hs-CRP CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMR0105 EUDAMEDCMR0102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359547611 EUDAMED06970150909017 EUDAMED
- Basic UDI-DI
- 697015090000042GY EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN 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
No
EUDAMED
hs-CRP 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 | 697015090000042GY | 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 (2)
- EUDAMED b9d956d8-c302-4971-8592-e5d0f99b387c 61 fields · synced Jul 16, 2026
- EUDAMED 3cb8e4c7-3533-4cf8-b8f5-d5879620bcc4 61 fields · synced May 19, 2026