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Ophtalmic RX Universel Hydrogel MF

by mark'ennovy Personalized Care S.L.

Ref 08445773221573Model Gentle Hydrogel Contact lenses

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 linked in EUDAMED

A group certificate may exist

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 Number8433108TF03-Gentle5C Basic UDI-DI 08445773221573UDI-DIDate23 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Gentle Hydrogel Contact lenses
Model / Reference
Gentle Hydrogel Contact lenses, 08445773221573
Primary DI / UDI-DI
08445773221573
Basic UDI-DI
8433108TF03-Gentle5C
EMDN Code
Q0210040102 Contact lenses - hydrogel, reusable
Device Class
Class IIa
Special Device Type
Made to order soft contact lenses
EU market of registration
France

Manufacturer details

EUDAMED SRN
ES-MF-000001436

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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