Taiwan FDA registration eb8304ea5a94960da2c376195ef8458b
“Puretone” Air Conduction Hearing Aid (Non-sterile)
TW: “普耳通”氣導式助聽器 (未滅菌)
Taiwan·Risk Class 1·MD·PURETONE LTD.·Registered Apr 07, 2014 – Apr 07, 2024ExpiredRegistration details
- Analysis ID
- eb8304ea5a94960da2c376195ef8458b
- License Form
- Ministry of Health Medical Device Import No. 014027
- Customs Code
- DHA09401402706
Company information
- Manufacturer
- PURETONE LTD.
- Manufacturer Country
- United Kingdom
- Authorized Representative
- JEN SOUND ENTERPRISE CO., LTD.
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
- Apr 07, 2014
- Expiry Date
- Apr 07, 2024
About this record
Access comprehensive regulatory information for “Puretone” Air Conduction 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 eb8304ea5a94960da2c376195ef8458b and manufactured by PURETONE LTD.. The authorized representative in Taiwan is JEN SOUND ENTERPRISE CO., LTD..
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