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Foille gel

by Farmaceutici Damor S.p.A.

Ref MDR/05

Foille gel (MDR/05) is a medical device (EU MDR Class IIb; EMDN category dressings for wounds) made by Farmaceutici Damor S.p.A., registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 805977787004MU) with CE/MDR certificate 0425-MDR-030193-01 valid until 25 May 2031, active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

25 May 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805977787004MU Basic UDI-DI 08059777870677UDI-DIDate21 Jul 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030193-01 Active Supplemented

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    7 Jul 2026
    Expires
    25 May 2031
    Reason
    Add device or group

Timeline

3 dated events

  1. Certificate issued EUDAMED 0425-MDR-030193-01
  2. Registered EUDAMED 805977787004MU
  3. Certificate expires EUDAMED 0425-MDR-030193-01

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Fitostimoline Idrogel
Model / reference
MDR/05
Primary DI / UDI-DI
08059777870677
Basic UDI-DI
805977787004MU
EMDN code
M040499 Dressings for wounds, sores and ulcerations - other
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000023738

Similar devices in this category

Other devices filed under DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER.

Other devices from Farmaceutici Damor S.p.A.

See all devices from Farmaceutici Damor S.p.A. →

Properties

Other properties (14, all answered No)