Taiwan FDA registration 8d60d3c4b1c634a4c42931c34cde445e
“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
Taiwan·Risk Class 3·MD·APOLLO ENDOSURGERY, INC.;;Apollo Endosurgery Costa Rica S.R.L.·Registered Mar 28, 2023 – Mar 28, 2028ActiveRegistration details
- Analysis ID
- 8d60d3c4b1c634a4c42931c34cde445e
- License Form
- Ministry of Health Medical Device Import No. 036254
- Customs Code
- DHA05603625406
Company information
- Manufacturer Country
- Costa Rica;;United States
- 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
- Mar 28, 2023
- Expiry Date
- Mar 28, 2028
About this record
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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