Taiwan FDA registration 446e31177e26a4f346bdaef2599038de
Longle hearing aids (unsterilized)
TW: 龍樂助聽器 (未滅菌)
Taiwan·Risk Class 1·SIVANTOS PTE LTD·Registered Mar 06, 2023 – Mar 06, 2028ActiveRegistration details
- Analysis ID
- 446e31177e26a4f346bdaef2599038de
- Customs Code
- DHA09402305805
Company information
- Manufacturer
- SIVANTOS PTE LTD
- Manufacturer Country
- Singapore
- Authorized Representative
- HEARWELL INTERNATIONAL 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
- Input;; QMS/QSD
Dates and status
- Registration Date
- Mar 06, 2023
- Expiry Date
- Mar 06, 2028
About this record
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..
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