Pure Global

“Biohit” Gastrin-17 Advanced - Taiwan Registration b9bf7822c69be948b70cbc110b733c21

Access comprehensive regulatory information for “Biohit” Gastrin-17 Advanced in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b9bf7822c69be948b70cbc110b733c21 and manufactured by BIOHIT OYJ. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY 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.

Free Database
Powered by Pure Global AI
89,000+ Devices
b9bf7822c69be948b70cbc110b733c21
Registration Details
Taiwan FDA Registration: b9bf7822c69be948b70cbc110b733c21
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

“Biohit” Gastrin-17 Advanced
TW: “百得” 胃泌素-17酵素免疫檢測試劑
Risk Class 2
MD

Registration Details

b9bf7822c69be948b70cbc110b733c21

Ministry of Health Medical Device Import No. 031116

DHA05603111608

Company Information

Finland

Product Details

This reagent uses enzyme-linked immunosorbent assay (ELISA) technology for the quantitative detection of G-17 (P-G-17) in human EDTA anticoagulant plasma or G-17 (S-G-17) in serum. The data of the test can be mainly used in two aspects: 1) when combined with other indicators (pepsinogen I, pepsinogen II) can assist in the diagnosis of gastric atrophic gastritis; 2) evaluate whether the gastric acid secretion is normal. This reagent is intended for in vitro diagnostic use and is not suitable for the diagnosis of gastrinomas.

A Clinical chemistry and clinical toxicology

A1325 Gastrin Test System

Imported from abroad

Dates and Status

May 22, 2018

May 22, 2028