Identity
- Trade Name
- Infivision EUDAMED
- Device Name
- Single-Use Electrode Belt EUDAMED
- Model / Reference
- Infivision EA400 EUDAMED104003011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974419900500 EUDAMED
- Basic UDI-DI
- 697441990CHNBJYYEITA4006T EUDAMED
- EMDN Code
- Z12062404 ELECTRODERMAL SIGNAL BIOFEEDBACK SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infivision by Infivision Medical Imaging Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697441990CHNBJYYEITA4006T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Infivision Medical Imaging Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000004093
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED 94569a75-b19a-4ac4-a7df-6b00f88b8ff5 61 fields · synced Jun 19, 2026