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Hialix®

by Gofarm Sp. z o.o. Sp. k.

Ref ENT12Model 24 lozenges

Active European Union

CE MDD

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/MDD NumberB-8435232341607ZS Basic UDI-DI D-8435232341607ZSUDI-DIDate7 Nov 2024RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Hialusept Blackcurrant
Model / Reference
24 lozenges, ENT12
Primary DI / UDI-DI
D-8435232341607ZS
Basic UDI-DI
B-8435232341607ZS
EMDN Code
Q0399 ENT devices - other
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
PL-MF-000003485

Other devices from Gofarm Sp. z o.o. Sp. k.

See all devices from Gofarm Sp. z o.o. Sp. k. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No