← Back to catalogue
Potassium Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref K6011Y, K6012Y, K6013Y, K6014Y, K6015Y, K6011N, K6012N, K6013N, K6014N, K6015N
Identity
- Trade Name
- Potassium Reagent Kit EUDAMED
- Device Name
- Potassium Reagent Kit EUDAMED
- Model / Reference
- K6011Y, K6012Y, K6013Y, K6014Y, K6015Y, K6011N, K6012N, K6013N, K6014N, K6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-K601FM EUDAMED
- Basic UDI-DI
- B-K601FM EUDAMED
- EMDN Code
- W01010308 POTASSIUM 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
Potassium 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-K601FM | 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 d0606b6d-b786-4147-b4d0-23becad023bc-1 61 fields · synced Jun 19, 2026
- EUDAMED d0606b6d-b786-4147-b4d0-23becad023bc-2 61 fields · synced Jun 19, 2026