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ETCO2 sensor

by Orantech Inc. China EUDAMED

Ref CTM-UC01

EMDN R020108

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06941691985389 Basic UDI-DIDate14 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CTM-UC01
Primary DI / UDI-DI
06941691985389
Basic UDI-DI
B-06941691985389
EMDN Code
R020108 Respiratory gas monitoring and sampling circuits and kits
Device Class
Class IIb
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000013859
Authorised representative
Medten EU ApS DK-AR-000034434

Other devices from Orantech Inc.

See all devices from Orantech Inc. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED eebbfc9d-8a1c-4826-a09d-9775b0d90132 61 fields · synced 24 Oct 2026