Skip to content

Careoxi

by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 5 variants

Part of a family of 10 devices: see the family page

Ref HAND T-NPWT DeviceModel Hand Handy T-NPWT Device

Careoxi (HAND T-NPWT Device) is a Class IIa device made by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-08683161110744), withdrawn as of 7 Nov 2026.

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDR, CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08683161110744 Basic UDI-DI 08683161110744UDI-DIDate28 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market
European UnionCE/MDD NumberB-08683161110744 Basic UDI-DI 08683161110744UDI-DIDate28 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Withdrawn

Specification

EUDAMED

Device name
Digital Hand Vacuum Assisted (NPWT) Wound Closure Therapy Device
Topivac Handy Wound Care Therapy Device
Model / reference
HAND T-NPWT Device, Hand Handy T-NPWT Device
Primary DI / UDI-DI
08683161110744
Basic UDI-DI
B-08683161110744, 868316111TOPIVACDEVST
Direct marketing DI
08683161110744
EMDN code
Z12019003 Wound treatment equipment
Device class
Class IIa
EU registration type
Legacy device (under a directive)
Standard device

Manufacturer details

EUDAMED SRN
TR-MF-000016889

Similar devices in this category

Other devices filed under WOUND TREATMENT EQUIPMENT.

Other devices from Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

Other properties (14, all answered No)