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“BIOTRONIK” Evity 8 Implantable Cardiac Pacemakers with a conditional intended use in a MRI environment - Taiwan Registration 556a43dfe83bd984248f6f6d54d9db33

Access comprehensive regulatory information for “BIOTRONIK” Evity 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 556a43dfe83bd984248f6f6d54d9db33 and manufactured by BIOTRONIK SE & CO. KG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.

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556a43dfe83bd984248f6f6d54d9db33
Registration Details
Taiwan FDA Registration: 556a43dfe83bd984248f6f6d54d9db33
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Device Details

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

Registration Details

556a43dfe83bd984248f6f6d54d9db33

Ministry of Health Medical Device Import No. 032636

DHA05603263600

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

Jun 17, 2019

Jun 17, 2024