Taiwan FDA registration 4b6a85339644497ec073ade059090f35

“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

Taiwan·Risk Class 2·MD·Boston Scientific Corporation·Registered May 20, 2022 – May 20, 2027Active

Registration details

Analysis ID: 4b6a85339644497ec073ade059090f35
License Form: Ministry of Health Medical Device Import No. 035491
Customs Code: DHA05603549102

Company information

Manufacturer: Boston Scientific Corporation
Manufacturer Country: United States
Authorized Representative: BOSTON SCIENTIFIC INTERNATIONAL B.V., TAIWAN BRANCH (NETHERLANDS)

Product details

Intended Use: 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.
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H4300 Electrosurgical device for endoscopes and accessories
Import Information: Imported from abroad

Dates and status

Registration Date: May 20, 2022
Expiry Date: May 20, 2027

About this record

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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