Taiwan FDA registration 93b746f3bc31ac7eafd8a12d21df7cc8

"OWANDY" Medical image communication device (Non-Sterile)

TW: "歐瓦" 醫學影像傳輸裝置 (未滅菌)

Taiwan·Risk Class 1·MD·OWANDY RADIOLOGY·Registered Apr 28, 2021 – Apr 28, 2026Expired

Registration details

Analysis ID: 93b746f3bc31ac7eafd8a12d21df7cc8
License Form: Ministry of Health Medical Device Import No. 022552
Customs Code: DHA09402255208

Company information

Manufacturer: OWANDY RADIOLOGY
Manufacturer Country: France
Authorized Representative: TEETH ART TECHNOLOGY CO., LTD.

Product details

Intended Use: Limited to the first-level recognition range of medical image transmission devices (P.2020) of the Measures for the Administration of Medical Devices.
Product Type (Level 1): P Devices for radiology
Product Type (Level 2): P2020 Medical Image Transmission Device
Import Information: Imported from abroad

Dates and status

Registration Date: Apr 28, 2021
Expiry Date: Apr 28, 2026

About this record

Access comprehensive regulatory information for "OWANDY" Medical image communication device (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 93b746f3bc31ac7eafd8a12d21df7cc8 and manufactured by OWANDY RADIOLOGY. The authorized representative in Taiwan is TEETH ART TECHNOLOGY 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.