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EasyMagPlex Antiphospholipid Syndrome IgM Kit
EUDAMEDClass IVD General (EU MDR)
Ref 340601HNE,340602HNE,340603HNE,340604HNE,340605HNE,340606HNEModel 50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)
Identity
- Device Name
- EasyMagPlex Antiphospholipid Syndrome IgM Kit EUDAMED
- Model / Reference
- 50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control) EUDAMED340601HNE,340602HNE,340603HNE,340604HNE,340605HNE,340606HNE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01169 EUDAMED
- Basic UDI-DI
- B-01169 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - 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 Antiphospholipid Syndrome IgM 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-01169 | 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 535eb16c-649a-47fe-a4e0-36082664ae95 61 fields · synced Jun 18, 2026
- EUDAMED 535eb16c-649a-47fe-a4e0-36082664ae95-1 61 fields · synced Jun 10, 2026