Taiwan FDA registration 36b8a8eff83cb8a0ea27ac2c6c65cf09

"Kangis Mei" hydrophilic and breathable artificial leather dressing (sterilized)

TW: “康是美”親水透氣人工皮敷料 (滅菌)

Taiwan·Risk Class 1·TRONJEN MEDICAL TECHNOLOGY INC.·Registered Feb 21, 2012 – Feb 21, 2027Active

Registration details

Analysis ID: 36b8a8eff83cb8a0ea27ac2c6c65cf09

Company information

Manufacturer: TRONJEN MEDICAL TECHNOLOGY INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: PRESIDENT DRUGSTORE BUSINESS CORPORATION

Product details

Intended Use: Limited to the first level recognition range of the classification and grading management measures for medical equipment "hydrophilic trauma covering materials (I.4018)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4018 親水性創傷覆蓋材
Import Information: 國產;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Feb 21, 2012
Expiry Date: Feb 21, 2027

About this record

Access comprehensive regulatory information for "Kangis Mei" hydrophilic and breathable artificial leather dressing (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 36b8a8eff83cb8a0ea27ac2c6c65cf09 and manufactured by TRONJEN MEDICAL TECHNOLOGY INC.. The authorized representative in Taiwan is PRESIDENT DRUGSTORE BUSINESS CORPORATION.

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.