Taiwan FDA registration 5132cab64e69765335bf6f5ed030ee04

"Helena" QuickGel Lactate Dehydrogenase Reagent kit (Non-sterile)

TW: "賀蓮那" 乳酸脫氫酶試劑組 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·HELENA LABORATORIES, INC.·Registered Aug 01, 2016 – Aug 01, 2021Expired
Registration details
Analysis ID
5132cab64e69765335bf6f5ed030ee04
License Form
Ministry of Health Medical Device Import No. 016853
Customs Code
DHA09401685300
Company information
Manufacturer Country
Japan
Authorized Representative
SHANG LI INSTRUMENTS CO., LTD.
Product details
Intended Use
Limited to the first level recognition range of lactate dehydrogenase test system (A.1440) of the management method for medical devices.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A1440 Lactate dehydrogenase test system
Import Information
Imported from abroad
Dates and status
Registration Date
Aug 01, 2016
Expiry Date
Aug 01, 2021
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About this record

Access comprehensive regulatory information for "Helena" QuickGel Lactate Dehydrogenase Reagent kit (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 5132cab64e69765335bf6f5ed030ee04 and manufactured by HELENA LABORATORIES, INC.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including HELENA LABORATORIES CORP., and 1 recent registrations in the same category. 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.

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