Taiwan FDA registration c1fcd13e01cd05060b053cb2e5190790

"Apolloendor" Obela 365 intragastric water balloon system

TW: “阿波羅恩朵”歐貝拉三六五胃內水球系統
Taiwan flagTaiwan·Risk Class 3·Apollo Endosurgery Costa Rica S.R.L.;; APOLLO ENDOSURGERY, INC.·Registered Mar 28, 2023 – Mar 28, 2028Active
Registration details
Analysis ID
c1fcd13e01cd05060b053cb2e5190790
Customs Code
DHA05603625406
Company information
Manufacturer Country
Costa Rica;;United States
Product details
Intended Use
Details are as detailed as approved Chinese instructions
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
Mar 28, 2023
Expiry Date
Mar 28, 2028
About this record

Access comprehensive regulatory information for "Apolloendor" Obela 365 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 c1fcd13e01cd05060b053cb2e5190790 and manufactured by Apollo Endosurgery Costa Rica S.R.L.;; APOLLO ENDOSURGERY, INC.. The authorized representative in Taiwan is BOSTON SCIENTIFIC INTERNATIONAL B.V., TAIWAN BRANCH (NETHERLANDS).

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