Taiwan FDA registration 2f7fb59f2a5432971ed8d5d5a82f73aa
SpotChem EZ "Arkray" (SP-4430)(Non-Sterile)
TW: "愛科來" 生化分析儀(未滅菌)
Taiwan·Risk Class 1·MD·Arkray Factory Inc., Head office factory·Registered Oct 01, 2021 – Oct 31, 2025ExpiredRegistration details
- Analysis ID
- 2f7fb59f2a5432971ed8d5d5a82f73aa
- License Form
- Ministry of Health Medical Device Import Registration No. 000472
- Customs Code
- DHA08400047205
Company information
- Manufacturer
- Arkray Factory Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- Fully automatic dry biochemical analyzer for detecting the concentration of biochemical reactions in human serum, plasma, whole blood (only for Hb).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A2160 Individual photometric chemistry analyzer for clinical use
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 01, 2021
- Expiry Date
- Oct 31, 2025
About this record
Access comprehensive regulatory information for SpotChem EZ "Arkray" (SP-4430)(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 2f7fb59f2a5432971ed8d5d5a82f73aa and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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