Skip to content

Artisential Clip Applier Large ACA03-FV

by Livsmed

Ref ACA03-FV

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

23 Feb 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800042706128 UDI-DI Date5 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number2024-MDR/QS-008/E Date31 Mar 2026IssuedStatusActive expires 23 Feb 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-008/E Active Amended

    Quality management system EU MDR

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

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
ACA03-FV
Primary DI / UDI-DI
08800042706128
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 10 Millimeter
Shaft Length — 38 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from Livsmed

See all devices from Livsmed →

Properties

  • 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