"Eligen" gastric water balloon system - Taiwan Registration c4f8a11ed1246af41e5cf1106a77f448
Access comprehensive regulatory information for "Eligen" gastric 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 c4f8a11ed1246af41e5cf1106a77f448 and manufactured by ALLERGAN COSTA RICA, S.R.L. The authorized representative in Taiwan is ERA BIOTEQ ENTERPRISE CO., LTD..
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Device Details
Product Details
Who is it for:? Patients with severe obesity (BMI > = 40, or BMI between 35 and 40 with obesity complications) can be used to temporarily lose weight and reduce the risk of surgery before undergoing bariatric surgery or other surgery. Weight loss can be achieved in patients who are significantly at risk to their health due to obesity and who are unable to achieve or maintain weight loss despite a tightly monitored weight program (BMI 30-39). However, patients must also systematically cooperate with a long-term diet and behavior monitoring and adjustment program to increase the likelihood of maintaining long-term weight loss. Patients with severe obesity who are unable to undergo bariatric surgery (BMI 40 or BMI 35 with obesity complications) can use this therapy to temporarily lose weight, combined with a long-term diet and behavior monitoring adjustment plan, to increase the likelihood of long-term weight loss.
H Gastroenterology and urology
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Dates and Status
Oct 31, 2007
Oct 31, 2017
Dec 13, 2019
Cancellation Information
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