Taiwan FDA registration 905bbe330f0c405ee816dd6cf472b3e2
“Arkray” SPOTCHEM II Fructosamine
TW: “愛科來”果糖胺試紙
Taiwan·Risk Class 2·MD·Arkray Factory Inc., Head office factory·Registered Dec 31, 2013 – Dec 31, 2028ActiveRegistration details
- Analysis ID
- 905bbe330f0c405ee816dd6cf472b3e2
- License Form
- Ministry of Health Medical Device Import No. 025739
- Customs Code
- DHA05602573906
Company information
- Manufacturer
- Arkray Factory Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- This product is used in conjunction with SPOTCHEM Analyzer to quantitatively measure fructosamine concentrations in serum or plasma.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B7470 Glycosylated heme analysis
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 31, 2013
- Expiry Date
- Dec 31, 2028
About this record
Access comprehensive regulatory information for “Arkray” SPOTCHEM II Fructosamine in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 905bbe330f0c405ee816dd6cf472b3e2 and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH 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