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Ellagyn

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

Ref WH01Model 50 ml, 50ml, 5 x 5 ml

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-59037695019778R Basic UDI-DI Date20 Aug 2025RegisteredStatusActive

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  • Withdrawn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
Vaginal gel/Żel dopochwowy
Żel dopochwowy
Model / Reference
50 ml, WH01, 50ml, 5 x 5 ml
Primary DI / UDI-DI
D-59037695019778R, 05903769501977
Basic UDI-DI
B-59037695019778R, 5906395089WH01B7
EMDN Code
M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Device Class
Class IIa
Class IIb
EU market of registration
Poland

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 (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