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“Digisine” Otoscope (Non-Sterile) - Taiwan Registration a12befda967411efe1ffd70de9b43a5f

Access comprehensive regulatory information for “Digisine” Otoscope (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a12befda967411efe1ffd70de9b43a5f and manufactured by Yuanhao Energy Co., Ltd. Linguang Processing Zone Plant. The authorized representative in Taiwan is Yuanhao Energy Co., Ltd. Linguang Processing Zone Plant.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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a12befda967411efe1ffd70de9b43a5f
Registration Details
Taiwan FDA Registration: a12befda967411efe1ffd70de9b43a5f
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Device Details

“Digisine” Otoscope (Non-Sterile)
TW: “元皓”耳鏡(未滅菌)
Risk Class 1
MD

Registration Details

a12befda967411efe1ffd70de9b43a5f

Ministry of Health Medical Device Manufacturing No. 009288

Company Information

Product Details

Limited to the first level identification range of the "Otoscope (G.4770)" of the Administrative Measures for the Classification and Grading of Medical Equipment.

G ENT device

G4770 Otoscope

Produced in Taiwan, China

Dates and Status

Sep 03, 2021

Sep 03, 2026