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PlasmaJet Neutral Plasma Surgery System

by Plasma Surgical, Inc. EUDAMED

Active European Union

Ref OS-CG-05-07H

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-++M397OSCG0507H0PK 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  • Withdrawn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

Device Name
PlasmaJet Neutral Plasma Handpiece with Holster
Model / Reference
OS-CG-05-07H
Primary DI / UDI-DI
++M397OSCG0507H0PK
Basic UDI-DI
B-++M397OSCG0507H0PK
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

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Properties

Show properties
  • 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