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ArtiSential Electrodes, Monopolar Series

by LivsMed Inc. South Korea EUDAMEDGUDID

Ref AMD01L-LV Product code GEIEMDN K0201010202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800042701628 UDI-DIDate28 Apr 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number2024-MDR/QS-009/D Date31 Mar 2026IssuedStatusActive expires 23 Feb 2029

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-009/D Amended

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    31 Mar 2026
    Expires
    23 Feb 2029
    Reason
    Mnf data change

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
ArtiSential Electrodes, Monopolar Series EUDAMED
Artisential Monopolar Precise Dissector GUDID
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use
Device Name
Laparoscopic Instruments - Electrodes
Model / Reference
AMD01L-LV
Primary DI / UDI-DI
08800042701628
Basic UDI-DI
88000427MonopolarS8
510(k) Number
FDA Product Code
GEI
EMDN Code
K0201010202 Laparoscopic and thoracoscopic electrosurgery dissectors, single-use
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Outer Diameter — 8 Millimeter
Shaft Length — 450 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

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 & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED ac59bbbd-dbdc-475e-930f-42a648021c00 61 fields · synced 23 Oct 2026
  • FDA UDI 4e767777-0216-4375-a872-7de57622573c 37 fields · synced 23 Oct 2026