Skip to content

Onecare

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

Ref KAFG12, KAF G55, KAFG65-1, KAFG65, KAFG64, KAFG07, KAF09, KAF10, KAFG05, KAFG67-3, ONCR002, KAFG04, KAFG67-4, KAFG01, KAFG64-4, KAFG67-1, KAFG66, KAFG65-3, KAFG64-1, KAFG64-3, KAFG67Model 50 PCS, 12 PCS

Active European Union

CE MDR 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/MDR NumberB-08682079003063 Basic UDI-DI Date9 Apr 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08682079003063 Basic UDI-DI Date9 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Incontinence Body Care Set
Onecare EEG Paste
Unit Table Cover
Barrier Cream Incontinence Wipes
Barrier Cream Incontinence Perineal Cloths
Adhesive Remover Spray
Model / Reference
KAFG12, KAF G55, KAFG65-1, KAFG65, KAFG64, 50 PCS, KAFG07, KAF09, KAF10, KAFG05, KAFG67-3, ONCR002, KAFG04, KAFG67-4, 12 PCS, KAFG01, KAFG64-4, KAFG67-1, KAFG66, KAFG65-3, KAFG64-1, KAFG64-3, KAFG67
Primary DI / UDI-DI
08682079003063, 08682560952573, 08682560953068, 08682560953051, 08682560953006, 08682022062253, 08682022062277, 08682022062284, 08682022062239, 08682560953181, 08682079003162, 08682022062222, 08682560953198, 08682022062208, 08682560953044, 08682560953167, 08682560953105, 08682560953082, 08682560953013, 08682560953037, 08682560953150
Basic UDI-DI
B-08682079003063, 868256095EEGST, 868256095UTCWG, B-08682022062253, B-08682022062277, B-08682022062284, B-08682022062239, 868256095YS56, B-08682022062222, B-08682022062208
Direct Marketing DI
08682560952573
08682560953068
08682560953006
08682560953181
08682079003162
08682560953198
08682560953044
08682560953167
08682560953105
08682560953082
08682560953013
08682560953037
08682560953150
EMDN Code
T99, Z12100385, T030199, M9003
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 (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