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Disposable Ultrasound Probe Covers

by Surgitools（Shanghai）Medical Instruments Co., Ltd. EUDAMED

Active European Union

Ref D801.505Model D801.5

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697144135D80154Q Basic UDI-DIDate28 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Disposable Ultrasound Probe Covers
Model / Reference
D801.5, D801.505
Primary DI / UDI-DI
06971441351959
Direct Marketing DI
06971441351959
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000055047
Authorised representative
Lotus NL B.V. NL-AR-000000121

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