Taiwan FDA registration 80cc486e9741453ec06c749e08f62ee4

"Juhong" air-directed hearing aids (unsterilized)

TW: "巨虹" 氣導式助聽器(未滅菌)

Taiwan·Risk Class 1·Renqi Enterprise Co., Ltd. Xinzhuang Factory;; Juhong Electronics Co., Ltd·Registered Sep 01, 2022 – Sep 01, 2027Active

Registration details

Analysis ID: 80cc486e9741453ec06c749e08f62ee4

Company information

Manufacturer: Renqi Enterprise Co., Ltd. Xinzhuang Factory;; Juhong Electronics Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: CHIP HOPE CO., LTD.

Product details

Intended Use: Limited to the first level recognition range of the classification and grading management measures for medical devices "hearing aids (G.3300)".
Product Type (Level 1): G ENT Science
Product Type (Level 2): G.3300 Hearing Aids
Import Information: 國產;; 委託製造;; QMS/QSD

Dates and status

Registration Date: Sep 01, 2022
Expiry Date: Sep 01, 2027

About this record

Access comprehensive regulatory information for "Juhong" air-directed hearing aids (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 80cc486e9741453ec06c749e08f62ee4 and manufactured by Renqi Enterprise Co., Ltd. Xinzhuang Factory;; Juhong Electronics Co., Ltd. The authorized representative in Taiwan is CHIP HOPE CO., LTD..

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