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External Telescope Simulator

by Samsara Vision Ltd.

Ref PR00107-00

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7290018786ETS2800107L9 Basic UDI-DI 07290018786055UDI-DIDate16 Sep 2025RegisteredStatusActive

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  • Withdrawn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
External Telescope Simulator 2.8X-FF Light
Model / Reference
PR00107-00
Primary DI / UDI-DI
07290018786055
Basic UDI-DI
7290018786ETS2800107L9
Direct Marketing DI
07290018786055
EMDN Code
Z1212012099 Instruments for the assessment of visual functionality - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IL-MF-000018630
Authorised representative
Obelis s.a. BE-AR-000000106

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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