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Eyonix

by Softjump Ltd

Ref EYR2BModel Eyonix R2

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50700044689EYR2BP3 Basic UDI-DI 05070004468903UDI-DIDate23 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Eyonix R2
Model / Reference
Eyonix R2, EYR2B
Primary DI / UDI-DI
05070004468903
Basic UDI-DI
50700044689EYR2BP3
Direct Marketing DI
05070004468903
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class I
Special Device Type
Software
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
UK-MF-000052239
Authorised representative
MedEnvoy Global BV NL-AR-000024028

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