Taiwan FDA registration 4b40fd9a70d7d39b2f6d7bc9c7261d7d
"Aibel" neonatal bilirubin tester (unsterilized)
TW: “愛貝兒”新生兒膽紅素測定儀(未滅菌)
Taiwan·Risk Class 1·CALL CO.,LTD·Registered Nov 15, 2012 – Nov 15, 2017CancelledRegistration details
- Analysis ID
- 4b40fd9a70d7d39b2f6d7bc9c7261d7d
- Customs Code
- DHA04401237207
Company information
- Manufacturer
- CALL CO.,LTD
- Manufacturer Country
- Japan
- Authorized Representative
- LINKSEAS TRADING CO., LTD.
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
- Input;; QMS/QSD
Dates and status
- Registration Date
- Nov 15, 2012
- Expiry Date
- Nov 15, 2017
- Cancellation Date
- Nov 17, 2019
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Aibel" neonatal 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 4b40fd9a70d7d39b2f6d7bc9c7261d7d and manufactured by CALL CO.,LTD. The authorized representative in Taiwan is LINKSEAS TRADING CO., LTD..
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