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C Reactive Protein (CRP)
EUDAMEDClass IVD General (EU MDR)
Ref D-837 002Ref D-837 000
Identity
- Trade Name
- C Reactive Protein (CRP) EUDAMED
- Device Name
- C Reactive Protein (CRP) EUDAMED
- Model / Reference
- D-837 002 EUDAMEDD-837 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182718572 EUDAMED62230182718336 EUDAMED
- Basic UDI-DI
- B-62230182718572 EUDAMEDB-62230182718336 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
Yes
EUDAMEDEUDAMED
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) by Kalians Corporation — 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-62230182718572 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 60643a87-5fd8-45e5-8444-a82ba06c9fb4 61 fields · synced Aug 2, 2026
- EUDAMED bed1660c-ae66-45f9-9566-b3001a9329fc 61 fields · synced Aug 2, 2026