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PlasmaJet Neutral Plasma Surgery System

by Plasma Surgical, Inc. 8 variants

Ref OS-CP-05-07H

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-++M397OSCP0507H0UC Basic UDI-DI ++M397OSCP0507H0UCUDI-DIDate12 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
PlasmaJet Neutral Plasma Handpiece with Holster
Model / Reference
OS-CP-05-07H
Primary DI / UDI-DI
++M397OSCP0507H0UC
Basic UDI-DI
B-++M397OSCP0507H0UC
EMDN Code
K020480 Devices for surgery with argon gas generator, single-use- accessories
Device Class
Class IIb
EU 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

  • 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