Taiwan FDA registration 9fb8aab85705120661bf18ebe27a2663
"Baite" uterine perfusion manipulation cannula
TW: “白特”子宮灌注操縱套管
Taiwan·Risk Class 2·拜爾德有限公司;; BIOTEQUE AMERICA, INC·Registered Sep 18, 2022 – Mar 26, 2025ExpiredRegistration details
- Analysis ID
- 9fb8aab85705120661bf18ebe27a2663
- Customs Code
- DHA05500768601
Company information
- Manufacturer
- 拜爾德有限公司;; BIOTEQUE AMERICA, INC
- Manufacturer Country
- Taiwan, Province of China;;United States
- Authorized Representative
- ZENSUN INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- l Obstetrics and Gynecology
- Product Type (Level 2)
- L.0002 Uterine manipulators/injection catheters
- Import Information
- Domestic;; Contract manufacturing;; Foreign commissioned domestic manufacturing, and then unified by foreign imports
Dates and status
- Registration Date
- Sep 18, 2022
- Expiry Date
- Mar 26, 2025
About this record
Access comprehensive regulatory information for "Baite" uterine perfusion manipulation cannula in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9fb8aab85705120661bf18ebe27a2663 and manufactured by 拜爾德有限公司;; BIOTEQUE AMERICA, INC. The authorized representative in Taiwan is ZENSUN INTERNATIONAL CO., LTD..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices