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“BIOTRONIK”Enitra 8 Implantable Cardiac Pacemakers with a conditional intended use in a MRI environment - Taiwan Registration aea7c8ee8fa166e6b9718aeddfee7251

Access comprehensive regulatory information for “BIOTRONIK”Enitra 8 Implantable 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 aea7c8ee8fa166e6b9718aeddfee7251 and manufactured by BIOTRONIK SE & CO. KG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.

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aea7c8ee8fa166e6b9718aeddfee7251
Registration Details
Taiwan FDA Registration: aea7c8ee8fa166e6b9718aeddfee7251
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Device Details

“BIOTRONIK”Enitra 8 Implantable Cardiac Pacemakers with a conditional intended use in a MRI environment
TW: “百多力”艾尼傳磁振造影植入式心律調節器
Risk Class 3
MD

Registration Details

aea7c8ee8fa166e6b9718aeddfee7251

Ministry of Health Medical Device Import No. 029999

DHA05602999900

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

Aug 07, 2017

Aug 07, 2027