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Dermalex Rosacea

by Farmaka srl

Ref E100 (Dermalex Rosacea BE); EA 107 (Aco Rosacea Nordic); E103 (Biodermal NL)

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, self-declared

Class I: no certifier involved

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-IT-MF-00002454502SS Basic UDI-DI D-IT-MF-00002454502SSUDI-DIDate20 Apr 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Farmaka Rosacea Cream (FRC)
Model / Reference
E100 (Dermalex Rosacea BE), EA 107 (Aco Rosacea Nordic), E103 (Biodermal NL)
Primary DI / UDI-DI
D-IT-MF-00002454502SS
Basic UDI-DI
B-IT-MF-00002454502SS
EMDN Code
M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
IT-MF-000024545

Other devices from Farmaka srl

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