Taiwan FDA registration 671c5912ec1182a94a717696ed02a854

"Hongkai" swab collection kit (sterilized)

TW: "虹錡" 拭子檢體採集套組(滅菌)

Taiwan·Risk Class 1·Yatai Technology Co., Ltd.; Hongkai Biotechnology Co., Ltd·Registered Nov 16, 2022 – Nov 16, 2027Active

Registration details

Analysis ID: 671c5912ec1182a94a717696ed02a854

Company information

Manufacturer: Yatai Technology Co., Ltd.; Hongkai Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: HONG CHI BIOTECH CO., LTD.

Product details

Intended Use: Limited to the classification and grading management measures for medical equipment "Microbial Sample Collection and Delivery Equipment (C.2900)" the first level identification range.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.2900 Microbial sample collection and delivery equipment
Import Information: 國產;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Nov 16, 2022
Expiry Date: Nov 16, 2027

About this record

Access comprehensive regulatory information for "Hongkai" swab collection kit (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 671c5912ec1182a94a717696ed02a854 and manufactured by Yatai Technology Co., Ltd.; Hongkai Biotechnology Co., Ltd. The authorized representative in Taiwan is HONG CHI 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.