Taiwan FDA registration 3614d248b37276957c70a3cc5fea7cb1

“Apollo Endosurgery” Intragastric Balloon BIB System

TW: “阿波羅恩朵”胃內水球系統
Taiwan flagTaiwan·Risk Class 3·MD·Apollo Endosurgery Costa Rica S.R.L.·Registered Sep 23, 2022 – Sep 23, 2027Active
Registration details
Analysis ID
3614d248b37276957c70a3cc5fea7cb1
License Form
Ministry of Health Medical Device Import No. 035909
Customs Code
DHA05603590901
Company information
Manufacturer Country
Costa Rica
Authorized Representative
ERA BIOTEQ ENTERPRISE CO., LTD.
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
H Gastroenterology and urology
Product Type (Level 2)
H1500 Endoscopes and accessories;; H9999 Other
Import Information
Imported from abroad
Dates and status
Registration Date
Sep 23, 2022
Expiry Date
Sep 23, 2027
About this record

Access comprehensive regulatory information for “Apollo Endosurgery” Intragastric Balloon BIB System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 3614d248b37276957c70a3cc5fea7cb1 and manufactured by Apollo Endosurgery Costa Rica S.R.L.. The authorized representative in Taiwan is ERA BIOTEQ ENTERPRISE CO., LTD..

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