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Sodium Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref Na6011Y, Na6012Y, Na6013Y, Na6014Y, Na6015Y, Na6011N, Na6012N, Na6013N, Na6014N, Na6015N
Identity
- Trade Name
- Sodium Reagent Kit EUDAMED
- Device Name
- Sodium Reagent Kit EUDAMED
- Model / Reference
- Na6011Y, Na6012Y, Na6013Y, Na6014Y, Na6015Y, Na6011N, Na6012N, Na6013N, Na6014N, Na6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-Na601ZS EUDAMED
- Basic UDI-DI
- B-Na601ZS EUDAMED
- EMDN Code
- W01010309 SODIUM 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
Sodium 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-Na601ZS | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 32da07f7-d083-41b3-a41c-e0aa127ec51f-1 61 fields · synced Jun 20, 2026
- EUDAMED 32da07f7-d083-41b3-a41c-e0aa127ec51f-2 61 fields · synced Jun 20, 2026