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ArtiSeal Vessel Sealing System - ArtiSeal Instruments

by LivsMed Inc. EUDAMED

Active European Union

Ref AS01S

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2025-MDR/QS-018/A Date31 Mar 2026IssuedStatusActive expires 4 Mar 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-018/A Amended

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    31 Mar 2026
    Expires
    4 Mar 2030
    Reason
    Mnf data change

Specification

EUDAMED

Device Name
Electrosurgical Units with Electrosurgery Instruments
Model / Reference
AS01S
Primary DI / UDI-DI
08800042703035
Basic UDI-DI
88000427ArtiSealI6R
EMDN Code
K0201010201,K0201010202
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011855
Authorised representative
Meridius Medical Europe Limited IE-AR-000004258

Other devices from LivsMed Inc.

See all devices from LivsMed Inc. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No