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Endoscope-i Smartphone Adapter

by Endoscope-i Ltd 34 variants

Ref ei12

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506077444ESAGM Basic UDI-DI 05060774440193UDI-DIDate9 Dec 2024RegisteredStatusActive

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  • Withdrawn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
Endoscope-i Smartphone Adapter
Model / Reference
ei12
Primary DI / UDI-DI
05060774440193
Basic UDI-DI
506077444ESAGM
Direct Marketing DI
05060774440193
EMDN Code
Z12021080 ENT endoscopy instruments - hardware accessories
Device Class
Class I
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
UK-MF-000044880
Authorised representative
CERT3GLOBAL, UNIPESSOAL, LDA. PT-AR-000037982

Other devices from Endoscope-i Ltd

See all devices from Endoscope-i 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