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Spo2 sensor

by Orantech Inc. China EUDAMED

Ref SS-077-AF30

EMDN C900301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06941691908333 Basic UDI-DIDate24 Jul 2026RegisteredStatusActive

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
SS-077-AF30
Primary DI / UDI-DI
06941691908333
Basic UDI-DI
B-06941691908333
EMDN Code
C900301 Pulse oximeter sensors
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 06941691908333|B-06941691908333 61 fields · synced 24 Oct 2026