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Glucose Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref GLU-HK6011Y,GLU-HK6012Y,GLU-HK6013Y,GLU-HK6014Y,GLU-HK6015Y,GLU-HK6011N,GLU-HK6012N,GLU-HK6013N,GLU-HK6014N,GLU-HK6015NRef GLU-OX6011Y,GLU-OX6012Y,GLU-OX6013Y,GLU-OX6014Y,GLU-OX6015Y,GLU-OX6011N,GLU-OX6012N,GLU-OX6013N,GLU-OX6014N,GLU-OX6015N
Identity
- Trade Name
- Glucose Reagent Kit EUDAMED
- Device Name
- Glucose Reagent Kit EUDAMED
- Model / Reference
- GLU-HK6011Y,GLU-HK6012Y,GLU-HK6013Y,GLU-HK6014Y,GLU-HK6015Y,GLU-HK6011N,GLU-HK6012N,GLU-HK6013N,GLU-HK6014N,GLU-HK6015N EUDAMEDGLU-OX6011Y,GLU-OX6012Y,GLU-OX6013Y,GLU-OX6014Y,GLU-OX6015Y,GLU-OX6011N,GLU-OX6012N,GLU-OX6013N,GLU-OX6014N,GLU-OX6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GLU-HK601BA EUDAMEDD-GLU-OX601GJ EUDAMED
- Basic UDI-DI
- B-GLU-HK601BA EUDAMEDB-GLU-OX601GJ EUDAMED
- EMDN Code
- W01010213 GLUCOSE 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
Glucose 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-GLU-HK601BA | 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 (5)
- EUDAMED c6dc47a8-3c79-42b2-936c-5d4964a482f8 61 fields · synced Jul 17, 2026
- EUDAMED 9e5e8515-13cf-41d2-b60f-d28eb7fa5f75 61 fields · synced May 18, 2026
- EUDAMED 9e5e8515-13cf-41d2-b60f-d28eb7fa5f75-1 61 fields · synced Jun 9, 2026
- EUDAMED c6dc47a8-3c79-42b2-936c-5d4964a482f8-1 61 fields · synced Jun 10, 2026
- EUDAMED 79a2111a-1ef0-41e1-9894-c9d87d0ebb2d-1 61 fields · synced Jul 14, 2026