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SpO2 Probe

by Acare Technology Co., Ltd. 3 variants

Ref ASWNR-D3Model ASWNR

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04719872741572 Basic UDI-DI 04719872741572UDI-DIDate27 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
ASWNR, ASWNR-D3
Primary DI / UDI-DI
04719872741572
Basic UDI-DI
B-04719872741572
EMDN Code
C900301 Pulse oximeter sensors
Device Class
Class IIb
EU market of registration
Malta

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

  • 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