Taiwan FDA registration 3797cef673f0d67a1c2fe7874af14f63

“Kometa-Bio” Dental operative unit and accessories (Non-Sterile)

TW: “皓美”牙科手術裝置及其附件(未滅菌)

Taiwan·Risk Class 1·MD·KOMETA-BIO LTD·Registered Aug 20, 2013 – Aug 20, 2023Expired

Registration details

Analysis ID: 3797cef673f0d67a1c2fe7874af14f63
License Form: Ministry of Health Medical Device Import No. 013320
Customs Code: DHA09401332002

Company information

Manufacturer: KOMETA-BIO LTD
Manufacturer Country: Israel
Authorized Representative: ROMANA ENTERPRISES LTD.

Product details

Intended Use: Limited to the first level identification range of dental surgical devices and their accessories (F.6640) under the Measures for the Administration of Medical Devices.
Product Type (Level 1): F Dental devices
Product Type (Level 2): F6640 Dental Surgical Devices and Their Accessories
Import Information: Imported from abroad

Dates and status

Registration Date: Aug 20, 2013
Expiry Date: Aug 20, 2023

About this record

Access comprehensive regulatory information for “Kometa-Bio” Dental operative unit and accessories (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 3797cef673f0d67a1c2fe7874af14f63 and manufactured by KOMETA-BIO LTD. The authorized representative in Taiwan is ROMANA ENTERPRISES LTD..

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