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Disposable ECG Electrodes - EUDAMED Registration 06939411511048

Access comprehensive regulatory information for Disposable ECG Electrodes 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 06939411511048 and manufactured by Baisheng Medical Co., Ltd. in China.

This page provides complete registration details including trade name (Disposable ECG Electrodes), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24), 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
06939411511048
No
Disposable ECG Electrodes
Trade Name: Disposable ECG Electrodes
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Device Description (EMDN)

ECG ELECTRODES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
C020501
Trade Name
Disposable ECG Electrodes
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06939411511048
Basic UDI
69394115301V7
Version Date
September 03, 2024
Manufacturer Last Update
May 31, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.11 Fusheng Road, Xinhui District Jiangmen
Email
baisheng@bs0750.com
Authorized Representative
SRN
DE-AR-000005129
Country
Germany
Address
56 Brehmstr Dรผsseldorf
Email
med@eulinx.eu
Telephone
+4921131054698
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Austria:None~None, Denmark:None~None, France:None~None, Germany:None~None, Greece:None~None, Ireland:None~None, Italy:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Romania:None~None, Spain:None~None, Tรผrkiye:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No