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“Apollo Endosurgery” ORBERA 365 Intragastric Balloon System - Taiwan Registration 8d60d3c4b1c634a4c42931c34cde445e

Access comprehensive regulatory information for “Apollo Endosurgery” ORBERA 365 Intragastric Balloon System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 8d60d3c4b1c634a4c42931c34cde445e and manufactured by APOLLO ENDOSURGERY, INC.;;Apollo Endosurgery Costa Rica S.R.L.. The authorized representative in Taiwan is ERA BIOTEQ ENTERPRISE CO., LTD..

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8d60d3c4b1c634a4c42931c34cde445e
Registration Details
Taiwan FDA Registration: 8d60d3c4b1c634a4c42931c34cde445e
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Device Details

“Apollo Endosurgery” ORBERA 365 Intragastric Balloon System
TW: “阿波羅恩朵”歐貝拉三六五胃內水球系統
Risk Class 3
MD

Registration Details

8d60d3c4b1c634a4c42931c34cde445e

Ministry of Health Medical Device Import No. 036254

DHA05603625406

Company Information

Product Details

Details are as detailed as approved Chinese instructions

H Gastroenterology and urology

H1500 Endoscopes and accessories;; H9999 Other

Imported from abroad

Dates and Status

Mar 28, 2023

Mar 28, 2028