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C-reactive Protein (CRP) Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref /Model RC-CRP1
Identity
- Device Name
- C-reactive Protein (CRP) Calibrator EUDAMED
- Model / Reference
- RC-CRP1 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-K91201-084G EUDAMED
- Basic UDI-DI
- B-K91201-084G EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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 Protein (CRP) Calibrator by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-K91201-084G | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 8593c1d0-2393-441b-882c-9b6828881b4c 61 fields · synced Jul 13, 2026