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Trojan

by Hpotech Medi̇kal Ve Tekni̇k Çözümler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref TKBO 1

Withdrawn Withdrawn in European Union.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

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682983709013 Basic UDI-DI 08682983709013UDI-DIDate29 Jul 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Device Name
Hpotech 1 Person Omega Hyperbaric Oxygen Therapy System
Model / Reference
TKBO 1
Primary DI / UDI-DI
08682983709013
Basic UDI-DI
B-08682983709013
EMDN Code
Z120308 Hyperbaric chambers
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
TR-MF-000032522

Other devices from Hpotech Medi̇kal Ve Tekni̇k Çözümler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Hpotech Medi̇kal Ve Tekni̇k Çözümler Sanayi̇ Ve Ti̇caret Anoni̇m 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