Identity
- Trade Name
- MagSi-DX Blood EUDAMED
- Device Name
- MagSi-DX Blood EUDAMED
- Model / Reference
- MDDX00020096 EUDAMEDMDDX00020960 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260350320098 EUDAMED04260350320005 EUDAMED
- Basic UDI-DI
- 426035032DX0002PJ EUDAMED
- Direct Marketing DI
- 04260350320098 EUDAMED04260350320005 EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
MagSi-DX Blood by magtivio B.V. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 426035032DX0002PJ | Class A | Active |
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Manufacturer
- Manufacturer
- magtivio B.V.
- EUDAMED SRN
- NL-MF-000023114
Sources (2)
- EUDAMED 664ee095-070e-4812-800d-5b4bd5cfd7d0 61 fields · synced Jul 15, 2026
- EUDAMED 008bc4ca-7e28-406c-a8e3-d029c9647878 61 fields · synced May 18, 2026