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Ecoplasma

by Sterifast - Sterilization & Disinfection Systems Lda. Portugal EUDAMED

Ref STFE1602SD-BModel ECOPLASMA E160 2SD-B

EMDN S900199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05600778703094 Basic UDI-DIDate6 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hydrogen Peroxide Low Temperature Sterilizer with Low Concentration
Model / Reference
ECOPLASMA E160 2SD-B, STFE1602SD-B
Primary DI / UDI-DI
05600778703094
Basic UDI-DI
B-05600778703094
EMDN Code
S900199 Devices for gas plasma sterilisation (excluding cat. d - z) - other
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PT-MF-000012426

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Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 31194262-8ce0-49ad-914e-b6403512cd57 61 fields · synced 22 Oct 2026