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C-reactive (hs-CRP and conventional CRP) Protein Reagent (Fluorescence Immunoch…
EUDAMEDClass IVD General (EU MDR)
Ref PO-0005-02Model PF02 50 tests/kit
Identity
- Trade Name
- C-reactive (hs-CRP and conventional CRP) Protein Reagent (Fluorescence Immunochromatography) EUDAMED
- Device Name
- C-reactive Protein Reagent (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- PF02 50 tests/kit EUDAMEDPO-0005-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377300376 EUDAMED
- Basic UDI-DI
- B-06941377300376 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
C-reactive (hs-CRP and conventional CRP) Protein Reagent (Fluorescence Immunoch… by Shenzhen Dymind Biotechnology 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-06941377300376 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED fbc70188-6f02-49f2-af28-50b5b5f7d66a 61 fields · synced Jun 18, 2026