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Low Temperature Steam-Formaldehyde Sterilizer

by Shinva Medical Instrument Co., Ltd. China EUDAMED

Ref FS-K130Model FS-130，FS-M130，FS-K130，FS-M220，FS-L130 EMDN Z12011303

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697061496120012R3 Basic UDI-DIDate16 Oct 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
FS-130，FS-M130，FS-K130，FS-M220，FS-L130, FS-K130
Primary DI / UDI-DI
06970614962022
Basic UDI-DI
697061496120012R3
EMDN Code
Z12011303 Chemical sterilisation equipment
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

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 06970614962022|697061496120012R3 61 fields · synced 25 Oct 2026