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Supersoft

by Dileh Medical supplies co., Ltd. 4 variants

Ref 30044

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471682013693410HW Basic UDI-DI 04716820130402UDI-DIDate20 Apr 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  • Withdrawn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 External Catheter
Model / Reference
30044
Primary DI / UDI-DI
04716820130402
Basic UDI-DI
471682013693410HW
Unit of Use DI
14716820130416
EMDN Code
U070201 Sheath catheter for the treatment of incontinence
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
TW-MF-000016927
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Dileh Medical supplies co., Ltd.

See all devices from Dileh Medical supplies 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