Pure Global

Defibrillation Electrodes - EUDAMED Registration 06939411510980

Access comprehensive regulatory information for Defibrillation 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 06939411510980 and manufactured by Baisheng Medical Co., Ltd. in China.

This page provides complete registration details including trade name (Defibrillation 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
06939411510980
No
Defibrillation Electrodes
Trade Name: Defibrillation Electrodes
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
C020401
Trade Name
Defibrillation Electrodes
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06939411510980
Basic UDI
69394115OBS-DEQ3
Version Date
May 14, 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
IE-AR-000034828
Country
Ireland
Address
1 Marine School Walk Dublin
Email
info@gardien.ltd
Telephone
+353 87 3898449
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Tรผrkiye
Device Characteristics
Human Tissues
No
Animal Tissues
No