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Onecare

by Kaf Grup Sağlik Hi̇zmetleri̇ İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 18 variants

Ref KAFG53

Active European Union

CE MDD

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/MDD NumberB-08682560952511 Basic UDI-DI 08682560952511UDI-DIDate9 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Incontinence Body Care Set
Model / Reference
KAFG53
Primary DI / UDI-DI
08682560952511
Basic UDI-DI
B-08682560952511
EMDN Code
T99 Protective devices and aids for incontinence (excluding personal protective equipment - PPE) - other
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000018530

Other devices from Kaf Grup Sağlik Hi̇zmetleri̇ İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Kaf Grup Sağlik Hi̇zmetleri̇ İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

Other properties (11)

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