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Mycofree

by ALMA s.r.l. 3 variants

Ref A004000063

Mycofree (A004000063) is a medical device (EU MDR Class IIa; EMDN category special dressings) made by ALMA s.r.l., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 805330089TD10MYCOGF) with CE/MDR certificate EPT 0477.MDR.25/5738 valid until 22 Sep 2029, active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

22 Sep 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Eurofins Product Testing Italy S.r.l.

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805330089TD10MYCOGF Basic UDI-DI 08053300890408UDI-DIDate25 Sep 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/5738 Active

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    13 Feb 2025
    Expires
    22 Sep 2029

Timeline

3 dated events

  1. Certificate issued EUDAMED EPT 0477.MDR.25/5738
  2. Registered EUDAMED 805330089TD10MYCOGF
  3. Certificate expires EUDAMED EPT 0477.MDR.25/5738

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
A004000063
Primary DI / UDI-DI
08053300890408
Basic UDI-DI
805330089TD10MYCOGF
EMDN code
M0499 Special dressings - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029690

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Properties

Other properties (14, all answered No)