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LOGIQ Totus, LOGIQ Totus HDU - EUDAMED Registration 00195278877116

Access comprehensive regulatory information for LOGIQ Totus, LOGIQ Totus HDU in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00195278877116 and manufactured by GE Ultrasound Korea Ltd in Republic of Korea.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Agence Nationale de Sécurité du Médicament et des Produits de Santé), 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 IIa
00195278877116
Yes
LOGIQ Totus, LOGIQ Totus HDU
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

INTERNAL ULTRASOUND SCANNERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z11040101
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
00195278877116
Basic UDI
8406821BUG00347HM
Version Date
February 07, 2025
Manufacturer Last Update
December 26, 2024
Active Status
Yes
Manufacturer
Manufacturer Name
GE Ultrasound Korea Ltd
Country
Republic of Korea
Country Type
NON_EU
Address
9 Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do
Email
yongseong.oh@gehealthcare.com
Authorized Representative
SRN
FR-AR-000000344
Country
France
Address
283 Rue de la Miniere BUC
Email
eudamed@gehealthcare.com
Regulatory Information
Competent Authority
Agence Nationale de Sécurité du Médicament et des Produits de Santé
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No