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eyemate®-SC

by Implandata Ophthalmic Products GmbH

Ref IMP210001

Active European Union

CE MDR

Valid until

1 Nov 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

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 Number2246552CE01 Date1 Jun 2026IssuedStatusActive expires 1 Nov 2030

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2246552TD01 Active Reissued

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Jun 2026
    Expires
    1 Jun 2031
  • 2246552CE01 Restricted

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Jun 2026
    Expires
    1 Nov 2030
    Reason
    Not on market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
eyemate®-SC Implant
Model / Reference
IMP210001
Primary DI / UDI-DI
04260648170206
Basic UDI-DI
426064817IMP217F
Direct Marketing DI
04260648170206
EMDN Code
J0702 Intraocular pressure monitoring implantable devices
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005431

Other devices from Implandata Ophthalmic Products GmbH

Properties

  • Sterile
  • Implantable
  • Measuring Function

Other properties (10)

  • 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