Taiwan FDA registration 53fce8d32c4fe4e357645034ebda1cfe
"Boermei" awakening ball set and its spare parts
TW: “博而美”甦醒球組及其零配件
Registration details
- Analysis ID
- 53fce8d32c4fe4e357645034ebda1cfe
Company information
- Manufacturer
- HSINER CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- TBMS INTERNATIONAL CORPORATION
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- D Anesthesiology
- Product Type (Level 2)
- D.5915 Hand emergency breathing apparatus
- Import Information
- Contract manufacturing;; Domestic
Dates and status
- Registration Date
- Nov 16, 2022
- Expiry Date
- Nov 16, 2027
About this record
Access comprehensive regulatory information for "Boermei" awakening ball set and its spare parts in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 53fce8d32c4fe4e357645034ebda1cfe and manufactured by HSINER CO., LTD.. The authorized representative in Taiwan is TBMS INTERNATIONAL CORPORATION.
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