Taiwan FDA registration 8cdf7da02a9daa0b9c8e41d6f137497d
"BAYER" Endorectal Balloon (Non-sterile)
TW: "拜爾" 直腸擴張器 (未滅菌)
Taiwan·Risk Class 1·MD·BAYER MEDICAL CARE INC.·Registered Sep 27, 2018 – Sep 27, 2023ExpiredRegistration details
- Analysis ID
- 8cdf7da02a9daa0b9c8e41d6f137497d
- License Form
- Ministry of Health Medical Device Import No. 019649
- Customs Code
- DHA09401964900
Company information
- Manufacturer
- BAYER MEDICAL CARE INC.
- Manufacturer Country
- United States
- Authorized Representative
- Varian Medical Systems Taiwan Co., Ltd.
Product details
- Intended Use
- Limited to the first level identification range of "rectal dilator (H.5450)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- H Gastroenterology-urology devices
- Product Type (Level 2)
- H5450 Rectal dilators
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 27, 2018
- Expiry Date
- Sep 27, 2023
About this record
Access comprehensive regulatory information for "BAYER" Endorectal Balloon (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8cdf7da02a9daa0b9c8e41d6f137497d and manufactured by BAYER MEDICAL CARE INC.. The authorized representative in Taiwan is Varian Medical Systems Taiwan Co., Ltd..
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