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“BIOTRONIK” Eluna 8 Implantable Pacemaker System with a conditional intended use in a MRI environment - Taiwan Registration fb6477b0aa9b61983c306b2198e9c557

Access comprehensive regulatory information for “BIOTRONIK” Eluna 8 Implantable Pacemaker System 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 fb6477b0aa9b61983c306b2198e9c557 and manufactured by BIOTRONIK SE & CO. KG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.

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fb6477b0aa9b61983c306b2198e9c557
Registration Details
Taiwan FDA Registration: fb6477b0aa9b61983c306b2198e9c557
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Device Details

“BIOTRONIK” Eluna 8 Implantable Pacemaker System with a conditional intended use in a MRI environment
TW: “百多力”艾路納核磁共振植入式心律調節器
Risk Class 3
MD
Cancelled

Registration Details

fb6477b0aa9b61983c306b2198e9c557

Ministry of Health Medical Device Import No. 027467

DHA05602746709

Company Information

Germany

Product Details

E Cardiovascular devices

E3610 Pulse generator for implantable heart rhythm apparatus

Imported from abroad

Dates and Status

Jul 23, 2015

Jul 23, 2020

Jun 16, 2022

Cancellation Information

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