Taiwan FDA registration 1cb6a5783f28ed8b94f7e04fdb65058e

"openM" Prosthetic and orthotic accessory (Non-Sterile)

TW: "歐爸"義肢及裝具用附件(未滅菌)

Taiwan·Risk Class 1·MD·OPENM INC.·Registered Apr 15, 2019 – Apr 15, 2024Expired

Registration details

Analysis ID: 1cb6a5783f28ed8b94f7e04fdb65058e
License Form: Ministry of Health Medical Device Import No. 020313
Customs Code: DHA09402031306

Company information

Manufacturer: OPENM INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: MENEY CO., LTD.

Product details

Intended Use: Limited to the first-level identification range of the Measures for the Administration of Medical Devices "Accessories for Prosthetics and Accessories for Accessories for Appliances (O.3025)".
Product Type (Level 1): o Equipment for physical medicine
Product Type (Level 2): O3025 Accessories for prosthetics and accessories
Import Information: Imported from abroad

Dates and status

Registration Date: Apr 15, 2019
Expiry Date: Apr 15, 2024

About this record

Access comprehensive regulatory information for "openM" Prosthetic and orthotic accessory (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 1cb6a5783f28ed8b94f7e04fdb65058e and manufactured by OPENM INC.. The authorized representative in Taiwan is MENEY 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.