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SpO2 Probe

by Acare Technology Co., Ltd. United States EUDAMED

Ref ASANR-F1Model ASANR

EMDN C900301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04719872741459 Basic UDI-DIDate27 May 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 22 Oct 2026

Model / Reference
ASANR, ASANR-F1
Primary DI / UDI-DI
04719872741459
Basic UDI-DI
B-04719872741459
EMDN Code
C900301 Pulse oximeter sensors
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TW-MF-000031298
Authorised representative
Surpass Biomedical Europe B.V. NL-AR-000038619

Related devices

Category: Pulse oximeter probe, single-use

Other devices from Acare Technology Co., Ltd.

See all devices from Acare Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8c554d35-2537-4f01-82fd-36171f4f5423 61 fields · synced 22 Oct 2026