Medical Device Manufacturer · TW , Taipei City

Copioumed International, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Copioumed International, Inc. General Hospital ✕

2 devices

1-2 of 2

Cleared Feb 26, 2026

Copioumed AAMI 3 Surgical Gown

General Hospital · 254d

Cleared Oct 04, 2023

Copioumed Chemotherapy Isolation Gown

General Hospital · 259d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026