Taiwan FDA registration 2639c768f3c615b7a7ed99b85c8eeb1f

"Vstrip" H. pylori Antigen Rapid Test (Non-Sterile)

TW: "飛確" 幽門桿菌抗原快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·MD·Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory·Registered Dec 02, 2016 – Dec 02, 2026Active

Registration details

Analysis ID: 2639c768f3c615b7a7ed99b85c8eeb1f
License Form: Ministry of Health Medical Device Manufacturing No. 006503

Company information

Manufacturer: Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: PANION & BF BIOTECH INC.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C0003 Helicobacter serological reagent
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Dec 02, 2016
Expiry Date: Dec 02, 2026

About this record

Access comprehensive regulatory information for "Vstrip" H. pylori Antigen Rapid Test (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 2639c768f3c615b7a7ed99b85c8eeb1f and manufactured by Baoling Fujin Biotechnology Co., Ltd. Xizhi Plant No. 2 Factory. The authorized representative in Taiwan is PANION & BF BIOTECH INC..

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.