Taiwan FDA registration bca53cc8b162c11facbdc9e7659be9bd

"Boston Scientific" Oberle 365 Intragastric Balloon System

TW: “波士頓科技”歐伯樂365胃內水球系統
Taiwan flagTaiwan·Risk Class 3·Apollo Endosurgery Costa Rica S.R.L.;; APOLLO ENDOSURGERY, INC.·Registered Mar 04, 2024 – Mar 04, 2029Active
Registration details
Analysis ID
bca53cc8b162c11facbdc9e7659be9bd
Customs Code
DHA05603710201
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 04, 2024
Expiry Date
Mar 04, 2029
About this record

Access comprehensive regulatory information for "Boston Scientific" Oberle 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 bca53cc8b162c11facbdc9e7659be9bd 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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