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Sing Imt

by Samsara Vision Ltd. 12 variants

Ref PR00118-00Model NG SI IMT 3X

Active European Union

CE MDR CE MDD

Valid until

22 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier mdc medical device certification GmbH

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 NumberD1027100022 Date23 Jul 2026IssuedStatusActive expires 22 Jul 2031
European UnionCE/MDD NumberB-07290018786048 Basic UDI-DI 07290018786048UDI-DIDate13 Mar 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • D1027100022 Active

    Technical documentation EU MDR

    Certifier
    mdc medical device certification GmbH 0483
    Issued
    23 Jul 2026
    Expires
    22 Jul 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
SING Implantable Miniature Telescope (IMT)
Implantable Miniature Telescope – SING IMT™
Model / Reference
PR00118-00, NG SI IMT 3X
Primary DI / UDI-DI
07290018786048
Basic UDI-DI
B-07290018786048, 7290018786NGSI00118C8
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

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

Other devices from Samsara Vision Ltd.

  • Sing Imt

    Class IIb

  • External Telescope Simulator

    Class I

  • Sing Imt

    Class IIb

  • Sing Imt

    Class IIb

  • Sing Imt

    Class IIb

  • Sing Imt

    Class IIb

See all devices from Samsara Vision Ltd. →

Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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