Skip to content

Silicone Protect + LARGE

by Urgo Healthcare Products Co., Ltd

Ref 3664492025520

Active European Union

CE MDR

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/MDR Number8851401UHPTF0109H Basic UDI-DI 03664492025520UDI-DIDate6 Jan 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Silicone Protect +
Model / Reference
3664492025520
Primary DI / UDI-DI
03664492025520
Basic UDI-DI
8851401UHPTF0109H
EMDN Code
M04010203 Fixation silicone dressings
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
TH-MF-000029677
Authorised representative
Compliance Management Solutions Europe LTD BG-AR-000020809

Other devices from Urgo Healthcare Products Co., Ltd

See all devices from Urgo Healthcare Products Co., Ltd →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No