Taiwan FDA registration 3b95807ca8c685c678b74e5ccbfe1b8b

"Shangdake" negative pressure regulator (unsterilized)

TW: “上岳” 負壓調節器(未滅菌)

Taiwan·Risk Class 1·Shangyue Technology Co., Ltd. Precision Factory·Registered Oct 01, 2021 – Oct 01, 2026Active

Registration details

Analysis ID: 3b95807ca8c685c678b74e5ccbfe1b8b

Company information

Manufacturer: Shangyue Technology Co., Ltd. Precision Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: EMG TECHNOLOGY CO., LTD.

Product details

Intended Use: Limited to the first level recognition range of the classification and grading management measures for medical equipment "Vacuum-powered body fluid absorption device (J.6740)".
Product Type (Level 1): J General hospital and personal use equipment
Product Type (Level 2): J.6740 Vacuum-powered fluid absorption apparatus
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Oct 01, 2021
Expiry Date: Oct 01, 2026

About this record

Access comprehensive regulatory information for "Shangdake" negative pressure regulator (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3b95807ca8c685c678b74e5ccbfe1b8b and manufactured by Shangyue Technology Co., Ltd. Precision Factory. The authorized representative in Taiwan is EMG TECHNOLOGY CO., LTD..

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