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EasyMagPlex Autoimmune Diabetes Kit
EUDAMEDClass IVD General (EU MDR)
Ref 340701HNE,340702HNE,340703HNE,340704HNE,340705HNE,340706HNE
Identity
- Device Name
- EasyMagPlex Autoimmune Diabetes Kit EUDAMED
- Model / Reference
- 340701HNE,340702HNE,340703HNE,340704HNE,340705HNE,340706HNE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-0166K EUDAMED
- Basic UDI-DI
- B-0166K EUDAMED
- EMDN Code
- W0102060199 DIABETES ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
EasyMagPlex Autoimmune Diabetes Kit by Hunan Wellgrow Biotech 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-0166K | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hunan Wellgrow Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000045201
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (2)
- EUDAMED ac1efb5d-2d6a-46d4-bdea-4f2e77ef5c9a 61 fields · synced Jul 20, 2026
- EUDAMED ac1efb5d-2d6a-46d4-bdea-4f2e77ef5c9a-1 61 fields · synced Jun 9, 2026