Skip to content

Relys®

by SILDEHA Swiss SA EUDAMED

Active European Union

Ref FXA01EP01V10

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764044938STLYSOLOFTHL Basic UDI-DIDate18 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CSQ0025240225 Supplemented

    Quality management system EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    27 Nov 2025
    Expires
    14 Jul 2029
    Reason
    Add device or group

Specification

EUDAMED

Device Name
sT-LysYal® Soluzione Oftalmica
Model / Reference
FXA01EP01V10
Primary DI / UDI-DI
07640449380085
Basic UDI-DI
764044938STLYSOLOFTHL
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CH-MF-000034348
Authorised representative
SILDEHA Pharma Srl IT-AR-000029496

Other devices from SILDEHA Swiss SA

See all devices from SILDEHA Swiss SA →

Properties

Show 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