"Apollondo" Obela intragastric water balloon system - Taiwan Registration 0ffa75831a70b6d01f1e2b25d344f6f7
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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Device Details
Registration Details
0ffa75831a70b6d01f1e2b25d344f6f7
DHA05603188200
Product Details
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.
H Gastroenterology and urology
H.1500 Internal Scope and its Annexes; H.9999 Miscellaneous
import
Dates and Status
Nov 29, 2018
Nov 29, 2023