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EasyMagPlex Infertility IgG Kit
EUDAMEDClass IVD General (EU MDR)
Ref 340801HNE,340802HNE,340803HNE,340804HNE,340805HNE,340806HNE
Identity
- Device Name
- EasyMagPlex Infertility IgG Kit EUDAMED
- Model / Reference
- 340801HNE,340802HNE,340803HNE,340804HNE,340805HNE,340806HNE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-0146F EUDAMED
- Basic UDI-DI
- B-0146F EUDAMED
- EMDN Code
- W010399 HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY REAGENTS - 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 Infertility IgG 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-0146F | 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 9e57d004-e38e-480c-9190-8cccae0bf07d 61 fields · synced Jul 12, 2026
- EUDAMED 9e57d004-e38e-480c-9190-8cccae0bf07d-1 61 fields · synced Jun 10, 2026