Taiwan FDA registration b01a72c04def4f8d2f672bca404fb7f6
Dartex TN95 Medical Protective Mask (Unsterilized)
TW: "達特世" TN95 醫用防護口罩 (未滅菌)
Taiwan·Risk Class 1·DRX BIO CO., LTD.·Registered Mar 02, 2023 – Mar 02, 2028ActiveRegistration details
- Analysis ID
- b01a72c04def4f8d2f672bca404fb7f6
Company information
- Manufacturer
- DRX BIO CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- DRX BIO CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of medical equipment classification and grading management measures "Medical clothing (I.4040)".
- Product Type (Level 1)
- I General, Plastic Surgery and Dermatology
- Product Type (Level 2)
- I.4040 Clothing for medical purposes
- Import Information
- QMS/QSD;; 國產
Dates and status
- Registration Date
- Mar 02, 2023
- Expiry Date
- Mar 02, 2028
About this record
Access comprehensive regulatory information for Dartex TN95 Medical Protective Mask (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b01a72c04def4f8d2f672bca404fb7f6 and manufactured by DRX BIO CO., LTD.. The authorized representative in Taiwan is DRX BIO 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.
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