Taiwan FDA registration 6f01eb2cbb929773de6cbeb715f24e18

"Arkra" starch hydrolytic enzyme test strip

TW: "愛科來" 澱粉水解酵素檢測試紙
Taiwan flagTaiwan·Risk Class 2·ARKRAY Factory, Inc., Head office factory·Registered Dec 22, 2005 – Dec 22, 2025Expired
Registration details
Analysis ID
6f01eb2cbb929773de6cbeb715f24e18
Customs Code
DHA00601572509
Company information
Manufacturer Country
Japan
Authorized Representative
SYNGEN BIOTECH CO., LTD.
Product details
Intended Use
SPOTCHEM II Amylase is an in vitro diagnostic test used in serum or plasma for the quantitative determination of Amylase, which is dedicated to SPOTCHEM instruments.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1070 澱粉酶試驗系統
Import Information
import
Dates and status
Registration Date
Dec 22, 2005
Expiry Date
Dec 22, 2025
About this record

Access comprehensive regulatory information for "Arkra" starch hydrolytic enzyme test strip in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6f01eb2cbb929773de6cbeb715f24e18 and manufactured by ARKRAY Factory, Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..

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