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EasyMagPlex Human Cytokine 12 Plex Kit (12 Plex Kit)
EUDAMEDClass IVD General (EU MDR)
Ref 281601HNE,281602HNE,281603HNE
Identity
- Device Name
- EasyMagPlex Human Cytokine 12 Plex Kit (12 Plex Kit) EUDAMED
- Model / Reference
- 281601HNE,281602HNE,281603HNE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-0216C EUDAMED
- Basic UDI-DI
- B-0216C EUDAMED
- EMDN Code
- W01030699 LYMPHOKINES /IMMUNMODULATORS - 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 Human Cytokine 12 Plex Kit (12 Plex Kit) by Hunan Wellgrow Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-0216C | 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 f17a2d77-1a16-4aed-99ca-38aa1454a3bb 61 fields · synced Jun 19, 2026
- EUDAMED f17a2d77-1a16-4aed-99ca-38aa1454a3bb-1 61 fields · synced Jun 10, 2026