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Pulse Oximeter

by Shenzhen Everbest Machinery lndustry Co., Ltd. China EUDAMED

Ref OX-98B

EMDN Z1203020408

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69511109OX-98BHK Basic UDI-DIDate9 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
OX-98B
Primary DI / UDI-DI
06951110998081
Basic UDI-DI
69511109OX-98BHK
Direct Marketing DI
06951110998081
EMDN Code
Z1203020408 Pulse oximeters
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000008730
Authorised representative
Lotus NL B.V. NL-AR-000000121

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 41adf768-c559-46a5-9670-1f4615485fc2 61 fields · synced 22 Oct 2026