Taiwan FDA registration eaa16a6f7e5925cdff29d4877b5a8473

“UNIMAX” Balloon Trocar System (sterile)

TW: “普威”球囊穿刺導引器(滅菌)

Taiwan·Risk Class 2·MD·Puwei International Co., Ltd. Yilan Factory·Registered Nov 14, 2021 – Nov 14, 2026Active

Registration details

Analysis ID: eaa16a6f7e5925cdff29d4877b5a8473
License Form: Ministry of Health Medical Device Manufacturing No. 007196

Company information

Manufacturer: Puwei International Co., Ltd. Yilan Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: UNIMAX MEDICAL SYSTEMS INC.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H1500 endoscope and accessories
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Nov 14, 2021
Expiry Date: Nov 14, 2026

About this record

Access comprehensive regulatory information for “UNIMAX” Balloon Trocar System (sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number eaa16a6f7e5925cdff29d4877b5a8473 and manufactured by Puwei International Co., Ltd. Yilan Factory. The authorized representative in Taiwan is UNIMAX MEDICAL SYSTEMS INC..

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