Taiwan FDA registration 9b551189c3eeb8b5803d9a3ec2b2f853
The Binding Site Optilite Alpha-1 Antitrypsin Kit
TW: 邦迪斯歐普羅Alpha-1抗胰蛋白酶分析套組
Registration details
- Analysis ID
- 9b551189c3eeb8b5803d9a3ec2b2f853
- License Form
- Ministry of Health Medical Device Import No. 032948
- Customs Code
- DHA05603294806
Company information
- Manufacturer
- THE BINDING SITE GROUP LTD
- Manufacturer Country
- United Kingdom
- Authorized Representative
- EVERLIGHT BIOTECH(TAIWAN) CO., LTD.
Product details
- Intended Use
- This product is paired with the Binding Site Plite Analyzer for in vitro quantitative analysis of alpha-1 antitrypsin in human serum, lithium heparin salt, or EDTA plasma.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5130 α-1-Antitrypsin Immunoassay System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 22, 2019
- Expiry Date
- Oct 22, 2024
About this record
Access comprehensive regulatory information for The Binding Site Optilite Alpha-1 Antitrypsin Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9b551189c3eeb8b5803d9a3ec2b2f853 and manufactured by THE BINDING SITE GROUP LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) 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 DatabasePowered by Pure Global AI89,000+ Devices