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MiiS Horus Scope

by Medimaging Integrated Solution Inc 10 variants

Ref MiiS Horus Scope DEC 100Model DEC series, EEC series

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 Number47198727110007T Basic UDI-DI 04719872711018UDI-DIDate22 May 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  • Withdrawn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
Digital Eye Fundus Camera (Lens)
Model / Reference
DEC series, EEC series, MiiS Horus Scope DEC 100
Primary DI / UDI-DI
04719872711018
Basic UDI-DI
47198727110007T
Direct Marketing DI
04719872711018
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
TW-MF-000009317
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Medimaging Integrated Solution Inc.

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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