← Back to catalogue
High Sensitivity C-Reactive Protein Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref HS-CRP6011Y,HS-CRP6012Y,HS-CRP6013Y,HS-CRP6014Y,HS-CRP6015Y,HS-CRP6011N,HS-CRP6012N,HS-CRP6013N,HS-CRP6014N,HS-CRP6015N
Identity
- Trade Name
- High Sensitivity C-Reactive Protein Reagent Kit EUDAMED
- Device Name
- High Sensitivity C-Reactive Protein Reagent Kit EUDAMED
- Model / Reference
- HS-CRP6011Y,HS-CRP6012Y,HS-CRP6013Y,HS-CRP6014Y,HS-CRP6015Y,HS-CRP6011N,HS-CRP6012N,HS-CRP6013N,HS-CRP6014N,HS-CRP6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HS-CRP6018H EUDAMED
- Basic UDI-DI
- B-HS-CRP6018H EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
High Sensitivity C-Reactive Protein Reagent Kit by Hangzhou Aichek Medical Technology 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-HS-CRP6018H | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 4a6c797c-6390-4cd8-a0a0-c953f8fa99c5-1 61 fields · synced Jun 18, 2026
- EUDAMED 4a6c797c-6390-4cd8-a0a0-c953f8fa99c5-2 61 fields · synced Jun 18, 2026