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Rosazel

by ALMA s.r.l.

Ref A004000038

Rosazel (A004000038) is a Class IIa device made by ALMA s.r.l., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 805330089TD08ROSAJX) with CE/MDR certificate EPT 0477.MDR.25/5742 valid until 22 Sep 2029, active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805330089TD08ROSAJX Basic UDI-DI 08053300890323UDI-DIDate25 Sep 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/5742 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.25/5742
  2. Registered EUDAMED 805330089TD08ROSAJX
  3. Certificate expires EUDAMED EPT 0477.MDR.25/5742

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Rosazel
Model / reference
A004000038
Primary DI / UDI-DI
08053300890323
Basic UDI-DI
805330089TD08ROSAJX
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)