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Certificate 2024-MDR/QS-009/D — LivsMed Inc.

MD Atlas
Documents

LivsMed Inc.

Certificate 2024-MDR/QS-009/D

Rev. 04Amended

Valid until: Feb 23, 2029

Certificate 2024-MDR/QS-009/D is a valid Quality management system issued to LivsMed Inc. and registered in EUDAMED. Valid until February 23, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/QS-009/D
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 5
Certificate ID: 22652024-MDR/QS-009/D04

Validity

Issued: Mar 31, 2026
Valid from: Mar 31, 2026
Valid until: Feb 23, 2029

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

2024-MDR/QS-009/CQuality management systemAmendedFeb 10, 2026 → Feb 23, 2029

Scope coverage

Class IIb3

3 scopes

Sterile Single use Laparoscopic Instruments Electrodes
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN

No

Conditions applicable

No

MOS outside EUDAMED

No

QMS/MOS type

Basic UDI-DI data and Class IIb

3EC International a.s.

Manufacturer

Manufacturer: LivsMed Inc.
Manufacturer SRN: KR-MF-000011855
Manufacturer country: South Korea

Covered devices

Laparoscopic Instruments - ElectrodesClass IIb
88000427BipolarN2
Laparoscopic Instruments - ElectrodesClass IIb
88000427MonopolarS8