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Full Range C-Reactive Protein (FR-CRP) Assay Kit (Latex-enhanced Scatter Turbid…
EUDAMEDClass IVD General (EU MDR)
Ref Package:1×100T，Volume:16 mL
Identity
- Trade Name
- Full Range C-Reactive Protein (FR-CRP) Assay Kit (Latex-enhanced Scatter Turbidimetry Method) EUDAMED
- Device Name
- Full Range C-Reactive Protein (FR-CRP) Assay Kit (Latex-enhanced Scatter Turbidimetry Method) EUDAMED
- Model / Reference
- Package:1×100T，Volume:16 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429026061 EUDAMED
- Basic UDI-DI
- B-06945429026061 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Full Range C-Reactive Protein (FR-CRP) Assay Kit (Latex-enhanced Scatter Turbid… by Shenzhen Comen Medical Instruments Co., LTD. — Class IVD General — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06945429026061 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 22ff521f-9603-44b2-8c75-af13a73b35e2 61 fields · synced Oct 6, 2026