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Fructosamine Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref FMN6011Y, FMN6012Y, FMN6013Y, FMN6014Y, FMN6015Y, FMN6011N, FMN6012N, FMN6013N, FMN6014N, FMN6015N
Identity
- Trade Name
- Fructosamine Reagent Kit EUDAMED
- Device Name
- Fructosamine Reagent Kit EUDAMED
- Model / Reference
- FMN6011Y, FMN6012Y, FMN6013Y, FMN6014Y, FMN6015Y, FMN6011N, FMN6012N, FMN6013N, FMN6014N, FMN6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FMN601CA EUDAMED
- Basic UDI-DI
- B-FMN601CA EUDAMED
- EMDN Code
- W01010210 FRUCTOSAMINE 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
Fructosamine 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-FMN601CA | 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 4abd5ed4-20b4-4e5a-a476-b6548f1a6e1e 61 fields · synced Jun 18, 2026
- EUDAMED 4abd5ed4-20b4-4e5a-a476-b6548f1a6e1e-1 61 fields · synced Jun 10, 2026