Taiwan FDA registration 4d234127f7de9b94aa0e2b946bd72521
"AGCOLA" Automatic Urine Analyzer AE-4020 (Unsterilized)
TW: “愛科來”自動尿液分析儀 AE-4020 (未滅菌)
Registration details
- Analysis ID
- 4d234127f7de9b94aa0e2b946bd72521
- Customs Code
- DHA04400467503
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 "Automatic Urinalysis System (A.2900)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2900 Automated urinalysis system
- Import Information
- import
Dates and status
- Registration Date
- Jun 08, 2006
- Expiry Date
- Jun 08, 2021
- Cancellation Date
- Sep 23, 2023
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for "AGCOLA" Automatic Urine Analyzer AE-4020 (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 4d234127f7de9b94aa0e2b946bd72521 and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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