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SIGNA Prime Elite - EUDAMED Registration 00195278601162

Access comprehensive regulatory information for SIGNA Prime Elite 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 00195278601162 and manufactured by GE Healthcare Tianjin Company Limited in China.

This page provides complete registration details including trade name (SIGNA Prime Elite), 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
00195278601162
Yes
SIGNA Prime Elite
Trade Name: SIGNA Prime Elite
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Device Description (EMDN)

CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z11050104
Trade Name
SIGNA Prime Elite
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00195278601162
Basic UDI
08406821BUG004837J
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
266 Jingsan Road Tianjin Airport Economic Area Tianjin
Email
Yun_Zhang@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
Türkiye
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