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Infivision

by Infivision Medical Imaging Technology Co., Ltd. China EUDAMED

Ref 104003013Model Infivision EA400

EMDN Z12062404

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697441990CHNBJYYEITA4006T Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Single-Use Electrode Belt
Model / Reference
Infivision EA400, 104003013
Primary DI / UDI-DI
06974419900487
Basic UDI-DI
697441990CHNBJYYEITA4006T
EMDN Code
Z12062404 Electrodermal signal biofeedback systems
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000004093
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Infivision Medical Imaging Technology Co., Ltd.

See all devices from Infivision Medical Imaging Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 57a8a239-b85b-4932-98c0-a32b9dbb48d1 61 fields · synced 24 Oct 2026