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C-reactive Protein Reagent (Fluorescence Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref PO-0005-01Model PF02 25 tests/kitModel PF02 25 tests/kit
Identity
- Trade Name
- C-reactive Protein Reagent (Fluorescence Immunochromatography) EUDAMED
- Device Name
- C-reactive Protein Reagent (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- PF02 25 tests/kit EUDAMEDPO-0005-01 EUDAMEDPF02 25 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377301465 EUDAMED06941377301489 EUDAMED
- Basic UDI-DI
- B-06941377301465 EUDAMEDB-06941377301489 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
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
C-reactive Protein Reagent (Fluorescence Immunochromatography) by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06941377301465 | 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 (2)
- EUDAMED 38ff1aa9-a991-4dc1-bf5a-ff7d3a2fdec5 61 fields · synced Jul 10, 2026
- EUDAMED f521f682-5138-4581-9334-2ab99761f8b2 61 fields · synced Jul 10, 2026