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Infivision

by Infivision Medical Imaging Technology Co., Ltd. 27 variants

Ref 104002013Model Infivision EA300

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697441990CHNBJYYEITA3006N Basic UDI-DI 06974419900166UDI-DIDate26 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Electrode Belt
Model / Reference
Infivision EA300, 104002013
Primary DI / UDI-DI
06974419900166
Basic UDI-DI
697441990CHNBJYYEITA3006N
EMDN Code
Z12062404 Electrodermal signal biofeedback systems
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000004093
Authorised representative
Wellkang Ltd XI-AR-000001836

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

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

Properties

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