Skip to content

Ultrasound Gels

by Suzhou Leapmed Healthcare Corporation China EUDAMED

Ref Sa40

EMDN Z11049099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694116500000002577 Basic UDI-DIDate27 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.26/6235 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    20 Jul 2026
    Expires
    25 Mar 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ultrasound Gels
Model / Reference
Sa40
Primary DI / UDI-DI
06941165062172
Basic UDI-DI
694116500000002577
EMDN Code
Z11049099 Various ultrasound instruments - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000013964
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 06941165062172|694116500000002577 61 fields · synced 24 Oct 2026