Taiwan FDA registration 0b840862910fb57fa5547aec4b692459

Oak Stereoscopic Medical Mask (Unsterilized)

TW: 歐克立體醫療口罩(未滅菌)

Taiwan·Risk Class 1·Xunying Optoelectronics Co., Ltd.; Ruizhi Biochemical Technology Co., Ltd·Registered Aug 24, 2021 – Aug 24, 2026Active

Registration details

Analysis ID: 0b840862910fb57fa5547aec4b692459

Company information

Manufacturer: Xunying Optoelectronics Co., Ltd.; Ruizhi Biochemical Technology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: OK BIOTECH CO., LTD.

Product details

Intended Use: Limited to the first level identification range of medical equipment classification and grading management measures "Medical clothing (I.4040)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4040 Clothing for medical purposes
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Aug 24, 2021
Expiry Date: Aug 24, 2026

About this record

Access comprehensive regulatory information for Oak Stereoscopic Medical Mask (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0b840862910fb57fa5547aec4b692459 and manufactured by Xunying Optoelectronics Co., Ltd.; Ruizhi Biochemical Technology Co., Ltd. The authorized representative in Taiwan is OK BIOTECH 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.