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Versana Premier, Versana Premier Lotus - EUDAMED Registration 00195278690418

Access comprehensive regulatory information for Versana Premier, Versana Premier Lotus 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 00195278690418 and manufactured by GE Medical Systems CO. Ltd in China.

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
00195278690418
Yes
Versana Premier, Versana Premier Lotus
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
00195278690418
Basic UDI
8406821BUG00189HT
Version Date
July 04, 2024
Manufacturer Last Update
February 13, 2023
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
19 ChangJiang Road WUXI
Email
JiongWu@ge.com
Authorized Representative
SRN
FR-AR-000000344
Country
France
Address
283 Rue de la Miniere BUC
Email
CoE.Postmarket@ge.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
France
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