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“Boston Scientific” Rezum Delivery Device Kit for BPH - Taiwan Registration 4b6a85339644497ec073ade059090f35

Access comprehensive regulatory information for “Boston Scientific” Rezum Delivery Device Kit for BPH in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4b6a85339644497ec073ade059090f35 and manufactured by Boston Scientific Corporation. The authorized representative in Taiwan is BOSTON SCIENTIFIC INTERNATIONAL B.V., TAIWAN BRANCH (NETHERLANDS).

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4b6a85339644497ec073ade059090f35
Registration Details
Taiwan FDA Registration: 4b6a85339644497ec073ade059090f35
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Device Details

“Boston Scientific” Rezum Delivery Device Kit for BPH
TW: “波士頓科技”銳準消融系統輸送裝置組
Risk Class 2
MD

Registration Details

4b6a85339644497ec073ade059090f35

Ministry of Health Medical Device Import No. 035491

DHA05603549102

Company Information

Product Details

The Rezum System is designed to relieve obstruction and associated symptoms caused by an enlarged prostate. It is suitable for men with prostate volume of 30~80cm3. It is also indicated for the treatment of hyperplasia in the central and/or middle lobe of the prostate.

H Gastroenterology and urology

H4300 Electrosurgical device for endoscopes and accessories

Imported from abroad

Dates and Status

May 20, 2022

May 20, 2027