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Sterile Single use Laparoscopic Instruments Electrodes - EUDAMED Registration 08800042701611

Access comprehensive regulatory information for Sterile Single use Laparoscopic Instruments Electrodes in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 08800042701611 and manufactured by LivsMed Inc. in Republic of Korea.

This page provides complete registration details including trade name (ArtiSential Laparoscopic Instruments-Electrodes), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class IIb
08800042701611
Yes
Sterile Single use Laparoscopic Instruments Electrodes
Trade Name: ArtiSential Laparoscopic Instruments-Electrodes
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Device Description (EMDN)

LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
K0201010202
Trade Name
ArtiSential Laparoscopic Instruments-Electrodes
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800042701611
Basic UDI
88000427MonopolarS8
Version Date
August 29, 2024
Manufacturer Last Update
August 18, 2021
Active Status
Yes
Manufacturer
Manufacturer Name
LivsMed Inc.
Country
Republic of Korea
Country Type
NON_EU
Address
700 Pangyo-ro, Bundangu Seongnam-si, Gyeonggi-do
Email
info@livsmed.com
Authorized Representative
SRN
IE-AR-000004258
Country
Ireland
Address
Unit 3D North Point House North Point Business Park New Mallow Road Cork
Email
ar@meridiusmedical.com
Telephone
+353 212066448
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Austria:2024-02-23~2029-02-23, Belgium:2024-02-23~2029-02-23, Bulgaria:2024-02-23~2029-02-23, Croatia:2024-02-23~2029-02-23, Cyprus:2024-02-23~2029-02-23, Czechia:2024-02-23~2029-02-23, Denmark:2024-02-23~2029-02-23, Estonia:2024-02-23~2029-02-23, Finland:2024-02-23~2029-02-23, France:2024-02-23~2029-02-23, Germany:2024-02-23~2029-02-23, Greece:2024-02-23~2029-02-23, Hungary:2024-02-23~2029-02-23, Iceland:2024-02-23~2029-02-23, Ireland:2024-02-23~2029-02-23, Italy:2024-02-23~2029-02-23, Latvia:2024-02-23~2029-02-23, Liechtenstein:2024-02-23~2029-02-23, Lithuania:2024-02-23~2029-02-23, Luxembourg:2024-02-23~2029-02-23, Malta:2024-02-23~2029-02-23, Netherlands:2024-02-23~2029-02-23, Norway:2024-02-23~2029-02-23, Poland:2024-02-23~2029-02-23, Portugal:2024-02-23~2029-02-23, Romania:2024-02-23~2029-02-23, Slovakia:2024-02-23~2029-02-23, Slovenia:2024-02-23~2029-02-23, Spain:2024-02-23~2029-02-23, Sweden:2024-02-23~2029-02-23, Tรผrkiye:2024-02-23~2029-02-23, United Kingdom (Northern Ireland only):2024-02-23~2029-02-23
Device Characteristics
Human Tissues
No
Animal Tissues
No