← Back to catalogue
Cystatin C Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref CYS-C6011Y, CYS-C6012Y, CYS-C6013Y, CYS-C6014Y, CYS-C6015Y, CYS-C6011N, CYS-C6012N, CYS-C6013N, CYS-C6014N, CYS-C6015N
Identity
- Trade Name
- Cystatin C Reagent Kit EUDAMED
- Device Name
- Cystatin C Reagent Kit EUDAMED
- Model / Reference
- CYS-C6011Y, CYS-C6012Y, CYS-C6013Y, CYS-C6014Y, CYS-C6015Y, CYS-C6011N, CYS-C6012N, CYS-C6013N, CYS-C6014N, CYS-C6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CYS-C601K6 EUDAMED
- Basic UDI-DI
- B-CYS-C601K6 EUDAMED
- EMDN Code
- W0102019008 CYSTATIN C 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
Cystatin C Reagent Kit by Hangzhou Aichek Medical Technology 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-CYS-C601K6 | 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 a8c95379-be07-484f-b301-422210afc571 61 fields · synced Jun 18, 2026
- EUDAMED a8c95379-be07-484f-b301-422210afc571-1 61 fields · synced Jun 10, 2026