Taiwan FDA registration 3545a6d1ce2a8942d6655b5566fb1c1f
"Eleflex" hydrogel wound dressing (sterilized)
TW: “怡美福”水凝膠傷口敷料(滅菌)
Registration details
- Analysis ID
- 3545a6d1ce2a8942d6655b5566fb1c1f
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- CORELEADER BIOTECH CO., LTD.
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
- QMS/QSD;; 委託製造;; 國產
Dates and status
- Registration Date
- Feb 05, 2020
- Expiry Date
- Feb 05, 2025
About this record
Access comprehensive regulatory information for "Eleflex" hydrogel 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 3545a6d1ce2a8942d6655b5566fb1c1f and manufactured by Canlide Biotech Co., Ltd.;; Zhongzhen Technology Co., Ltd. The authorized representative in Taiwan is CORELEADER BIOTECH CO., LTD..
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