Taiwan FDA registration 1fe7a5ade3dc21ca7492f26d9e565632
"Arkray" SPOTCHEM D-03 (SD-4820) (Non-sterile)
TW: "愛科來" 生化分析系統 (未滅菌)
Taiwan·Risk Class 1·MD·ARKRAY Factory, Inc.,Head office factory·Registered Sep 23, 2022 – Oct 31, 2023ExpiredRegistration details
- Analysis ID
- 1fe7a5ade3dc21ca7492f26d9e565632
- License Form
- Ministry of Health Medical Device Import Registration No. a00116
- Customs Code
- DHA084a0011603
Company information
- Manufacturer
- ARKRAY Factory, Inc.,Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of the "Individual Photometric Chemistry Analyzer for Clinical Use (A.2160)" of the Measures for the Classification and Grading of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A2160 Individual photometric chemistry analyzer for clinical use
Dates and status
- Registration Date
- Sep 23, 2022
- Expiry Date
- Oct 31, 2023
About this record
Access comprehensive regulatory information for "Arkray" SPOTCHEM D-03 (SD-4820) (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 1fe7a5ade3dc21ca7492f26d9e565632 and manufactured by ARKRAY Factory, Inc.,Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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