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H2O2 Low Temperature Plasma Sterilizer

by Shinva Medical Instrument Co., Ltd. China EUDAMED

Ref PS-100XModel PS-40X,PS-100X,PS-100XP,PS-100GXP,PS-150X,GS-100X EMDN Z12011309

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697061496120004R4 Basic UDI-DIDate28 Mar 2025RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
PS-40X, PS-100X, PS-100XP, PS-100GXP, PS-150X, GS-100X
Primary DI / UDI-DI
06970614964965
Basic UDI-DI
697061496120004R4
EMDN Code
Z12011309 Plasma sterilisers
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000009856
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Related devices

Category: Plasma sterilizer

Other devices from Shinva Medical Instrument Co., Ltd.

See all devices from Shinva Medical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED cee190e8-5b55-4139-9222-7f01be0ea789 61 fields · synced 24 Oct 2026