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Onepix

by Unident AB

Ref OPX001Model Onepix

Active European Union

CE MDR

Valid until

16 Dec 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

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 Number735011864OPXK8 Basic UDI-DI 07350118640012UDI-DIDate12 Jan 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Onepix 2.x
Model / Reference
Onepix, OPX001
Primary DI / UDI-DI
07350118640012
Basic UDI-DI
735011864OPXK8
Direct Marketing DI
07350118640012
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000004887

Other devices from Unident AB

See all devices from Unident AB →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No