Taiwan FDA registration 84398c1da321faee5fc69b05ac27373a
"Okutai" perivalvular leak closure
TW: “奧庫泰”瓣周漏封堵器
Taiwan·Risk Class 3·Occlutech Tibbi Urunler San. Ve Tic. Ltd. Sti.;;Occlutech GmbH·Registered Jun 13, 2018 – Jun 13, 2028ActiveRegistration details
- Analysis ID
- 84398c1da321faee5fc69b05ac27373a
- Customs Code
- DHA05603077007
Company information
- Manufacturer Country
- Türkiye;;Germany
- Authorized Representative
- MEDICARE UNITECH INC.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E.9999 Miscellaneous
- Import Information
- Input;; Security Surveillance;; The use of this device shall comply with the provisions of the Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing.
Dates and status
- Registration Date
- Jun 13, 2018
- Expiry Date
- Jun 13, 2028
About this record
Access comprehensive regulatory information for "Okutai" perivalvular leak closure in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 84398c1da321faee5fc69b05ac27373a and manufactured by Occlutech Tibbi Urunler San. Ve Tic. Ltd. Sti.;;Occlutech GmbH. The authorized representative in Taiwan is MEDICARE UNITECH INC..
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