Skip to content

Omni Power System

by Scivita Medical Technology Co., Ltd. United States EUDAMED

Ref PS-100

EMDN Z12080201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697138125038A93 Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
PS-100
Primary DI / UDI-DI
06971381254914
Basic UDI-DI
697138125038A93
Direct Marketing DI
06971381254914
EMDN Code
Z12080201 Endometrial ablation equipment
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010305
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Scivita Medical Technology Co., Ltd.

See all devices from Scivita Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Measuring Function
Other properties (11)
  • Sterile: No
  • Implantable: 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 06971381254914|697138125038A93 61 fields · synced 24 Oct 2026