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Hidrocor

by Solotica Industria e Comercio Ltda

Ref 0388Model Solotica Contact Lens

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number78990316LENTES35 Basic UDI-DI 78990316HEJFUDI-DIDate12 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  • Withdrawn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
Solotica Contact Lens
Model / Reference
Solotica Contact Lens, 0388
Primary DI / UDI-DI
78990316HEJF
Basic UDI-DI
78990316LENTES35
EMDN Code
Q0210040102 Contact lenses - hydrogel, reusable
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
BR-MF-000015792
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Solotica Industria E Comercio Ltda

See all devices from Solotica Industria E Comercio Ltda →

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