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Hpotech MEDITERRANEAN 1 Person Omega Hyperbaric Oxygen Therapy System

by Hpotech Medi̇kal Ve Tekni̇k Çözümler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref TKBO-3X

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 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/MDR Number8682983709TKBOSFTW4C Basic UDI-DI 08682983709105UDI-DIDate28 Jul 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Monoplace Omega Hyperbaric Oxygen Therapy System
Model / Reference
TKBO-3X
Primary DI / UDI-DI
08682983709105
Basic UDI-DI
8682983709TKBOSFTW4C
Direct Marketing DI
08682983709105
EMDN Code
Z120308 Hyperbaric chambers
Device Class
Class IIb
EU market of registration
Türkiye

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 (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