Taiwan FDA registration 2508b163c2361414912f94eff483ea8c

"Luma" Medical Hot and Cold Pack (Unsterilized)

TW: “璐瑪” 醫療用冷熱包 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Luma Enterprises Limited;; Zhongyi Industrial Co., Ltd. new housing factory·Registered May 10, 2023 – Oct 31, 2025Expired
Registration details
Analysis ID
2508b163c2361414912f94eff483ea8c
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
LU MARK ENTERPRISES INC.
Product details
Intended Use
Limited to the classification and grading management of medical equipment, the first level identification range of "Medical Hot and Cold Compress Device (O.5700)".
Product Type (Level 1)
o Physical Medical Sciences
Product Type (Level 2)
O.5700 醫療用冷熱敷裝置
Dates and status
Registration Date
May 10, 2023
Expiry Date
Oct 31, 2025
About this record

Access comprehensive regulatory information for "Luma" Medical Hot and Cold Pack (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2508b163c2361414912f94eff483ea8c and manufactured by Luma Enterprises Limited;; Zhongyi Industrial Co., Ltd. new housing factory. The authorized representative in Taiwan is LU MARK ENTERPRISES INC..

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