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rinoLYSYAL®

by SILDEHA Pharma Srl 2 variants

Ref 0SLD700C3E

Active European Union

CE MDR

Valid until

18 Jan 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ISTITUTO SUPERIORE DI SANITA'

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 Number805720449TLYSCRERIN26 Basic UDI-DI 08057204490184UDI-DIDate2 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CSQ0005230326 Active Supplemented

    Quality management system EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    31 Mar 2026
    Expires
    18 Jan 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
T-LysYal® Crema Mucosa Nasale
Model / Reference
0SLD700C3E
Primary DI / UDI-DI
08057204490184
Basic UDI-DI
805720449TLYSCRERIN26
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026622

Other devices from SILDEHA Pharma Srl

  • proctoLYSYAL®

    Class IIb

  • rinoLYSYAL®

    Class IIb

  • repaLYSYAL®

    Class IIb

Properties

Other properties (13)

  • Sterile: No
  • 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