Taiwan FDA registration 0ffa75831a70b6d01f1e2b25d344f6f7

"Apollondo" Obela intragastric water balloon system

TW: “阿波羅恩朵”歐貝拉胃內水球系統

Taiwan·Risk Class 3·APOLLO ENDOSURGERY INC;; Apollo Endosurgery Costa Rica S.R.L.·Registered Nov 29, 2018 – Nov 29, 2023Expired

Registration details

Analysis ID: 0ffa75831a70b6d01f1e2b25d344f6f7
Customs Code: DHA05603188200

Company information

Manufacturer: APOLLO ENDOSURGERY INC;; Apollo Endosurgery Costa Rica S.R.L.
Manufacturer Country: Costa Rica;;United States
Authorized Representative: ERA BIOTEQ ENTERPRISE CO., LTD.

Product details

Intended Use: This system is a temporary weight loss therapy for overweight patients with a body mass index (BMI INDEX) of 27kg/m2 or above. The system should implement clinical diet monitoring for long-term weight loss and regular behavior modification medical plan. The maximum insertion period is 6 months, and the water balloon must be removed within the placement period.
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H.1500 Internal Scope and its Annexes; H.9999 Miscellaneous
Import Information: import

Dates and status

Registration Date: Nov 29, 2018
Expiry Date: Nov 29, 2023

About this record

Access comprehensive regulatory information for "Apollondo" Obela intragastric water 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 0ffa75831a70b6d01f1e2b25d344f6f7 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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