Taiwan FDA registration 3e5af01e2ed8ee495b2e54530453a8a4
"Ruisen" water film wound dressing (sterilized)
TW: "瑞森" 水膠片裝傷口敷料 (滅菌)
Registration details
- Analysis ID
- 3e5af01e2ed8ee495b2e54530453a8a4
Company information
- Manufacturer
- Zhuohe Enterprise Co., Ltd. (Wugu Factory)
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- RECENTTEC INC.
Product details
- Intended Use
- Limited to the first level of classification and grading management of medical equipment "Waterborne Wound and Burn Covering (I.4022)".
- Product Type (Level 1)
- I General, Plastic Surgery and Dermatology
- Product Type (Level 2)
- I.4022 Water-based wounds and burn covers
- Import Information
- 國產;; QMS/QSD;; 委託製造
Dates and status
- Registration Date
- Mar 22, 2016
- Expiry Date
- Mar 22, 2026
About this record
Access comprehensive regulatory information for "Ruisen" water film wound 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 3e5af01e2ed8ee495b2e54530453a8a4 and manufactured by Zhuohe Enterprise Co., Ltd. (Wugu Factory). The authorized representative in Taiwan is RECENTTEC INC..
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.
Free DatabasePowered by Pure Global AI89,000+ Devices