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UCSol Debridement

by WELCARE INDUSTRIES S.p.A. 2 variants

Ref 95160FModel 95160

UCSol Debridement (95160F) is a Class IIb device made by WELCARE INDUSTRIES S.p.A., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 803397672SOL951606570XT) with CE/MDR certificate EPT 0477.MDR.23/5201.1 valid until 9 Jul 2028, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

9 Jul 2028

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803397672SOL951606570XT Basic UDI-DI 08033976721558UDI-DIDate2 Oct 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.23/5201.1 Active Reissued

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    30 Nov 2023
    Expires
    9 Jul 2028

Timeline

3 dated events

  1. Certificate issued EUDAMED EPT 0477.MDR.23/5201.1
  2. Registered EUDAMED 803397672SOL951606570XT
  3. Certificate expires EUDAMED EPT 0477.MDR.23/5201.1

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
95160, 95160F
Primary DI / UDI-DI
08033976721558
Basic UDI-DI
803397672SOL951606570XT
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-000020870

Similar devices in this category

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

Other devices from WELCARE INDUSTRIES S.p.A.

See all devices from WELCARE INDUSTRIES S.p.A. →

Properties

  • Supplied sterile
Other properties (13, all answered No)