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Longle hearing aids (unsterilized) - Taiwan Registration 446e31177e26a4f346bdaef2599038de

Access comprehensive regulatory information for Longle 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 446e31177e26a4f346bdaef2599038de and manufactured by SIVANTOS PTE LTD. The authorized representative in Taiwan is HEARWELL INTERNATIONAL CO., LTD..

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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446e31177e26a4f346bdaef2599038de
Registration Details
Taiwan FDA Registration: 446e31177e26a4f346bdaef2599038de
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Device Details

Longle hearing aids (unsterilized)
TW: ้พๆจ‚ๅŠฉ่ฝๅ™จ (ๆœชๆป…่Œ)
Risk Class 1

Registration Details

446e31177e26a4f346bdaef2599038de

DHA09402305805

Company Information

Singapore

Product Details

Limited to the first level recognition range of the classification and grading management measures for medical devices "hearing aids (G.3300)".

G ENT Science

G.3300 Hearing Aids

Input;; QMS/QSD

Dates and Status

Mar 06, 2023

Mar 06, 2028