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ArtiSential Clip Applier

by LivsMed Inc. South Korea EUDAMEDGUDID

Ref ACA03S-FV Product code GDOEMDN H020303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800042706142 UDI-DIDate5 Jun 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number2024-MDR/QS-008/E 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-008/E 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 Clip Applier EUDAMED
Artisential Clip Applier Large GUDID
Generic Name
Endoscopic surgical ligation clip applier, single-use
Device Name
Laparoscopic Instruments – Clip Appliers
Model / Reference
ACA03S-FV
Primary DI / UDI-DI
08800042706142
Basic UDI-DI
88000427ClipApplierKM
FDA Product Code
GDO
EMDN Code
H020303 Clip appliers
GMDN Term
Endoscopic surgical ligation clip applier, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Size
Outer Diameter — 10 Millimeter
Shaft Length — 25 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

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
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • 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
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED f24a484b-02ee-42c7-b223-d32c758bc8c7 61 fields · synced 23 Oct 2026
  • FDA UDI 3b8527fe-b48b-4fde-bb83-a1dae70292a3 36 fields · synced 23 Oct 2026