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“BIOTRONIK” Enitra 6 Implantabl Cardiac Pacemakers with a conditional intended use in a MRI environment - Taiwan Registration 57c7c2bff9c0e37884438fec338adf04

Access comprehensive regulatory information for “BIOTRONIK” Enitra 6 Implantabl Cardiac Pacemakers with a conditional intended use in a MRI environment in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 57c7c2bff9c0e37884438fec338adf04 and manufactured by BIOTRONIK SE & CO. KG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.

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57c7c2bff9c0e37884438fec338adf04
Registration Details
Taiwan FDA Registration: 57c7c2bff9c0e37884438fec338adf04
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Device Details

“BIOTRONIK” Enitra 6 Implantabl Cardiac Pacemakers with a conditional intended use in a MRI environment
TW: “百多力”艾尼傳六磁振造影植入式心律調節器
Risk Class 3
MD

Registration Details

57c7c2bff9c0e37884438fec338adf04

Ministry of Health Medical Device Import No. 030908

DHA05603090800

Company Information

Germany

Product Details

For details, it is Chinese approved copy of the imitation order

E Cardiovascular devices

E3610 Pulse generator for implantable heart rhythm apparatus

Imported from abroad

Dates and Status

May 30, 2018

May 30, 2028