Taiwan FDA registration 35fd15d983c148019070d5bc0e5a8b41
"Tone-E" A&M Hearing Aid (Non-Sterile)
TW: 統一助聽器(未滅菌)
Taiwan·Risk Class 1·MD·SIVANTOS GMBH·Registered Dec 13, 2017 – Dec 13, 2022ExpiredRegistration details
- Analysis ID
- 35fd15d983c148019070d5bc0e5a8b41
- License Form
- Ministry of Health Medical Device Import No. 018601
- Customs Code
- DHA09401860106
Company information
- Manufacturer
- SIVANTOS GMBH
- Manufacturer Country
- Singapore
- Authorized Representative
- Unify the hearing aid line
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Hearing Aids (G.3300)".
- Product Type (Level 1)
- G ENT device
- Product Type (Level 2)
- G3300 hearing aid
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 13, 2017
- Expiry Date
- Dec 13, 2022
About this record
Access comprehensive regulatory information for "Tone-E" A&M Hearing Aid (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 35fd15d983c148019070d5bc0e5a8b41 and manufactured by SIVANTOS GMBH. The authorized representative in Taiwan is Unify the hearing aid line.
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