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Disposable SPO2 Sensor

by Shenzhen Pray-Med Tech Co., Ltd. China EUDAMED

Ref PS1H0010

EMDN Z1203020685

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06975207310587 Basic UDI-DIDate30 Apr 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
PS1H0010
Primary DI / UDI-DI
06975207310587
Basic UDI-DI
B-06975207310587
EMDN Code
Z1203020685 Vital signs telemetry instruments - consumables
Device Class
Class IIb
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038508
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Pray-Med Tech 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 934ec17b-c529-4fa0-8ccb-8030e897b5fc 61 fields · synced 22 Oct 2026