Taiwan FDA registration 53716165ef97a95452fa1a05f104a566

"Okutai" perimembranous ventricular middle diaphragm defect closure device

TW: “奧庫泰” 膜周邊型心室中膈缺損封堵器
Taiwan flagTaiwan·Risk Class 3·Occlutech Medical Products San. Ve Tic. Ltd. Sti.;;Occlutech GmbH·Registered Apr 30, 2023 – Apr 30, 2028Active
Registration details
Analysis ID
53716165ef97a95452fa1a05f104a566
Customs Code
DHA05603635601
Company information
Manufacturer Country
Türkiye;;Germany
Authorized Representative
MEDICARE UNITECH INC.
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
E Cardiovascular Medicine Science
Product Type (Level 2)
E.9999 Miscellaneous
Import Information
import
Dates and status
Registration Date
Apr 30, 2023
Expiry Date
Apr 30, 2028
About this record

Access comprehensive regulatory information for "Okutai" perimembranous ventricular middle diaphragm defect closure device in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 53716165ef97a95452fa1a05f104a566 and manufactured by Occlutech Medical Products San. Ve Tic. Ltd. Sti.;;Occlutech GmbH. The authorized representative in Taiwan is MEDICARE UNITECH INC..

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