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1.5T HD 8Ch Cardiac Array - EUDAMED Registration 00840682119504

Access comprehensive regulatory information for 1.5T HD 8Ch Cardiac Array in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00840682119504 and manufactured by GE Healthcare Coils in United States.

This page provides complete registration details including trade name (1.5T HD 8CH CARDIAC ARRAY ), 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 I
00840682119504
Yes
1.5T HD 8Ch Cardiac Array
Trade Name: 1.5T HD 8CH CARDIAC ARRAY
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Device Description (EMDN)

MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z1105018001
Trade Name
1.5T HD 8CH CARDIAC ARRAY
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840682119504
Basic UDI
8406821BUG00361HF
Version Date
April 11, 2024
Manufacturer Last Update
February 14, 2024
Active Status
Yes
Manufacturer
Manufacturer Name
GE Healthcare Coils
Country
United States
Country Type
NON_EU
Address
1515 Danner Drive Aurora
Email
Nicholas.Threasher@gehealthcare.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, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No