Taiwan FDA registration 891410d9b8e55f4268d35239b0649f08
"Hetai" powder-free examination gloves (unsterilized)
TW: “合泰” 無粉檢診手套(未滅菌)
Registration details
- Analysis ID
- 891410d9b8e55f4268d35239b0649f08
- Customs Code
- DHA09402258000
Company information
- Manufacturer
- MAXTER GLOVE MANUFACTURING SDN. BHD.
- Manufacturer Country
- Malaysia
- Authorized Representative
- HOLTECH BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- Limited to the first level of identification scope of the Measures for the Classification and Grading of Medical Equipment "Gloves for Patient Examination (J.6250)".
- Product Type (Level 1)
- J General hospital and personal use equipment
- Product Type (Level 2)
- J.6250 病患檢查用手套
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jul 08, 2021
- Expiry Date
- Jul 08, 2026
About this record
Access comprehensive regulatory information for "Hetai" powder-free examination gloves (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 891410d9b8e55f4268d35239b0649f08 and manufactured by MAXTER GLOVE MANUFACTURING SDN. BHD.. The authorized representative in Taiwan is HOLTECH BIOTECHNOLOGY CO., LTD..
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