Taiwan FDA registration 68e1de3f4b6ad040903daf3b84695346
"Apel" bilirubin tester (unsterilized)
TW: "亞沛爾" 膽紅素測試儀(未滅菌)
Taiwan·Risk Class 1·CALL CO.,LTD·Registered Sep 18, 2006 – Sep 18, 2021CancelledRegistration details
- Analysis ID
- 68e1de3f4b6ad040903daf3b84695346
- Customs Code
- DHA04400515903
Company information
- Manufacturer
- CALL CO.,LTD
- Manufacturer Country
- Japan
- Authorized Representative
- SCIENSER INTERNATIONAL INC.
Product details
- Intended Use
- Limit the first level identification range of the neonatal bilirubin (total and unconjugated) test system (A.1113) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1113 Neonatal bilirubin (total and unconjugated) test system
- Import Information
- import
Dates and status
- Registration Date
- Sep 18, 2006
- Expiry Date
- Sep 18, 2021
- Cancellation Date
- Oct 12, 2023
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Apel" bilirubin tester (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 68e1de3f4b6ad040903daf3b84695346 and manufactured by CALL CO.,LTD. The authorized representative in Taiwan is SCIENSER INTERNATIONAL INC..
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