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ArtiSeal Vessel Sealing System - ArtiSeal Instruments

by LivsMed Inc. 4 variants

Ref AS01M-FModel AS01S

Active European Union

CE MDR

Valid until

4 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

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

Certificates

1 certificate · EUDAMED

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

    Quality management system EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Electrosurgical Units with Electrosurgery Instruments
Model / Reference
AS01S, AS01M-F
Primary DI / UDI-DI
08800042703295
Basic UDI-DI
88000427ArtiSealI6R
EMDN Code
K0201010201, K0201010202
Device Class
Class IIb
EU 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