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Pulse oximeter

by AViTA Corporation Taiwan EUDAMED

Ref SP64

EMDN Z1203020408

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471095342TCF07SPXNB Basic UDI-DIDate6 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
SP64
Primary DI / UDI-DI
04710953425022
Basic UDI-DI
471095342TCF07SPXNB
Direct Marketing DI
04710953425022
EMDN Code
Z1203020408 Pulse oximeters
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000010455
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Avita Corporation

See all devices from Avita Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 04710953425022|471095342TCF07SPXNB 61 fields · synced 23 Oct 2026