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ECG Electrode - EUDAMED Registration 15060842920234

Access comprehensive regulatory information for ECG Electrode 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 15060842920234 and manufactured by Nissha Medical Technologies Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Corpuls), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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
15060842920234
No
ECG Electrode
Trade Name: Corpuls
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Device Description (EMDN)

ECG ELECTRODES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
C020501
Trade Name
Corpuls
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
15060842920234
Basic UDI
50604419ECG-Elec7UN
Version Date
February 18, 2025
Manufacturer Last Update
August 23, 2021
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Nissha Medical Technologies Ltd Torbay Business Park TQ4 7HP Paignton
Email
uksales@nisshamedical.com
Authorized Representative
SRN
FR-AR-000009795
Country
France
Address
23-25 Boulevard de la Paix Cergy
Email
FRquality@nisshamedical.com
Telephone
+33 1 39 72 66 66
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
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, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No