Identity
- Trade Name
- MagDEA Dx SV 400 12gC EUDAMED
- Device Name
- MagDEA Dx SV 400 12gC EUDAMED
- Model / Reference
- magLEAD IC card EUDAMEDI7812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987869978120 EUDAMED
- Basic UDI-DI
- 4987869ICSV40012gCRJ EUDAMED
- EMDN Code
- W02060192 ROBOTIC SAMPLE PROCESSING SYSTEMS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
MagDEA Dx SV 400 12gC by Precision System Science Co., Ltd. — 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 | 4987869ICSV40012gCRJ | Class A | Active |
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Manufacturer
- Manufacturer
- Precision System Science Co., Ltd.
- EUDAMED SRN
- JP-MF-000029061
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a33102d2-462c-4506-bc54-a50b0a0cbf35 61 fields · synced Jun 19, 2026