Skip to content

PlasmaJet Neutral Plasma Surgery System

by Plasma Surgical, Inc. United States EUDAMED

Ref S2-CDU-07H EMDN K020480

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-++M397S2CDU07H0AT Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
PlasmaJet Neutral Plasma Handpiece w/Holster
Model / Reference
S2-CDU-07H
Primary DI / UDI-DI
++M397S2CDU07H0AT
Basic UDI-DI
B-++M397S2CDU07H0AT
EMDN Code
K020480 Devices for surgery with argon gas generator, single-use- accessories
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000008505
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Plasma Surgical, Ltd.

See all devices from Plasma Surgical, Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • 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 762cb4e9-288e-4fee-a0b0-61d7c1ce33ab 61 fields · synced 22 Oct 2026