Taiwan FDA registration 0ed51f72eb617da4273dcf19c0953bae

"Ruisen" waterproof and breathable film (unsterilized)

TW: "瑞森" 防水透氣護膜 (未滅菌)

Taiwan·Risk Class 1·Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Dec 25, 2015 – Dec 25, 2025Expired

Registration details

Analysis ID: 0ed51f72eb617da4273dcf19c0953bae

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 identification scope of the "Medical Adhesive Tapes and Adhesive Bandages (J.5240)" Classification and Grading Management Measures for Medical Equipment.
Product Type (Level 1): J General hospital and personal use equipment
Product Type (Level 2): J.5240 Adhesive tapes and adhesive bandages for medical use
Import Information: QMS/QSD;; 委託製造;; 國產

Dates and status

Registration Date: Dec 25, 2015
Expiry Date: Dec 25, 2025

About this record

Access comprehensive regulatory information for "Ruisen" waterproof and breathable film (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0ed51f72eb617da4273dcf19c0953bae and manufactured by Zhuohe Enterprise Co., Ltd. (Wugu Factory). The authorized representative in Taiwan is RECENTTEC INC..

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