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PlasmaJet

by Plasma Surgical, Inc. United States EUDAMED

Ref PlasmaJet

EMDN K020499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-PlasmaJetRL Basic UDI-DIDate20 Apr 2022RegisteredStatusActive

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 25 Oct 2026

Model / Reference
PlasmaJet
Primary DI / UDI-DI
D-PlasmaJetRL
Basic UDI-DI
B-PlasmaJetRL
EMDN Code
K020499 Devices for surgery with argon gas generator, single-use - other
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 D-PLASMAJETRL|B-PLASMAJETRL 61 fields · synced 25 Oct 2026