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Twinvisc

by Hyaltech Ltd. 2 variants

Ref 003500-0071-637Model TWINVISC

Expiring European Union

CE MDR

Valid until

1 Sep 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2250469CE01 Date8 Sep 2026IssuedStatusExpiring expires 1 Sep 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2250469CE01 Expiring Supplemented Expires in 304 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    8 Sep 2026
    Expires
    1 Sep 2027
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Ophthalmic Viscosurgical Device
Model / Reference
TWINVISC, 003500-0071-637
Primary DI / UDI-DI
05060105141003
Basic UDI-DI
506010514_OVD004_JW
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000019761
Authorised representative
Carl Zeiss Meditec AG DE-AR-000007733

Other devices from Hyaltech Ltd.

See all devices from Hyaltech Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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