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High Flow Oxygen Therapy Device

by Biçakçilar Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref RD0101Model Corensis Oxymax

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 Number86840320RD0101BQ Basic UDI-DI 08695476080155UDI-DIDate20 May 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  • Withdrawn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
High Flow Oxygen Therapy Device
Model / Reference
Corensis Oxymax, RD0101
Primary DI / UDI-DI
08695476080155
Basic UDI-DI
86840320RD0101BQ
EMDN Code
R060202 Oxygen administration humidification systems
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022603

Other devices from Biçakçilar Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Biçakçilar Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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