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Copper Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref Cu6011Y, Cu6012Y, Cu6013Y, Cu6014Y, Cu6015Y, Cu6011N, Cu6012N, Cu6013N, Cu6014N, Cu6015N
Identity
- Trade Name
- Copper Reagent Kit EUDAMED
- Device Name
- Copper Reagent Kit EUDAMED
- Model / Reference
- Cu6011Y, Cu6012Y, Cu6013Y, Cu6014Y, Cu6015Y, Cu6011N, Cu6012N, Cu6013N, Cu6014N, Cu6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-Cu6012G EUDAMED
- Basic UDI-DI
- B-Cu6012G EUDAMED
- EMDN Code
- W01010206 COPPER 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
Category: Copper IVD, reagent
Copper Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-Cu6012G | 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 451f510a-7f1c-4a3a-9dac-75209f3266ce-1 61 fields · synced Jul 30, 2026
- EUDAMED 451f510a-7f1c-4a3a-9dac-75209f3266ce-2 61 fields · synced Jul 30, 2026