Pure Global

"Helena" Immunodiagnostic System (Non-Sterile) - Taiwan Registration fa68a55e8887f586665dc4e4a91100db

Access comprehensive regulatory information for "Helena" Immunodiagnostic System (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 fa68a55e8887f586665dc4e4a91100db and manufactured by HELENA LABORATORIES CORP.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS 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
fa68a55e8887f586665dc4e4a91100db
Registration Details
Taiwan FDA Registration: fa68a55e8887f586665dc4e4a91100db
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

"Helena" Immunodiagnostic System (Non-Sterile)
TW: "ๆตทๅ€ซ้‚ฃ" ๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ (ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

fa68a55e8887f586665dc4e4a91100db

Ministry of Health Medical Device Import No. 017933

DHA09401793300

Company Information

United States

Product Details

Limited to the first level identification range of the Measures for the Administration of Medical Devices "Human Whole Plasma or Serum Immunoassay System (C.5700)".

C Immunology and microbiology devices

C5700 Human whole plasma or serum immunoassay system

Imported from abroad

Dates and Status

Jun 07, 2017

Jun 07, 2022