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ArtiSential Electrodes, Monopolar Series

by LivsMed Inc. 51 variants

Ref AMHD01L-F

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

CE MDR

Valid until

23 Feb 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800042700584 UDI-DI Date29 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number2024-MDR/QS-009/D Date31 Mar 2026IssuedStatusActive expires 23 Feb 2029

Certificates

1 certificate · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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 Electrodes, Monopolar Series EUDAMED
Artisential Monopolar Hook GUDID
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use
Device Name
Laparoscopic Instruments - Electrodes
Model / Reference
AMHD01L-F
Primary DI / UDI-DI
08800042700584
Basic UDI-DI
88000427MonopolarS8
510(k) Number
FDA Product Code
GEI
EMDN Code
K0201010302 Lapar and thoracoscopic electrosurgery electrodes, single-use
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Shaft Length — 450 Millimeter
Outer Diameter — 8 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

  • 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