← Back to catalogue
EasyMagPlex Rheumatoid Arthritis IgM Kit
EUDAMEDClass IVD General (EU MDR)
Ref 341401HNE,341402HNE,341403HNE,341404HNE,341405HNE,341406HNE
Identity
- Device Name
- EasyMagPlex Rheumatoid Arthritis IgM Kit EUDAMED
- Model / Reference
- 341401HNE,341402HNE,341403HNE,341404HNE,341405HNE,341406HNE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-0136D EUDAMED
- Basic UDI-DI
- B-0136D EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS 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 Rheumatoid Arthritis 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-0136D | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
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 c83b164b-de61-4d60-8ff8-0f96d4f62d03 61 fields · synced Jul 17, 2026
- EUDAMED c83b164b-de61-4d60-8ff8-0f96d4f62d03-1 61 fields · synced Jun 9, 2026