Taiwan FDA registration a929c304530244c8dbb179daf9902956

Gerelier neonatal bilirubin (total and unbound) test system (unsterilized)

TW: "捷瑞兒"新生兒膽紅素(總量及未結合的)試驗系統(未滅菌)

Taiwan·Risk Class 1·Gerium Medical Ltd.·Registered Mar 03, 2015 – Mar 03, 2020Cancelled

Registration details

Analysis ID: a929c304530244c8dbb179daf9902956
Customs Code: DHA09401495600

Company information

Manufacturer: Gerium Medical Ltd.
Manufacturer Country: Israel
Authorized Representative: WISDOM UNION ENTERPRISE 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: QMS/QSD;; 輸入

Dates and status

Registration Date: Mar 03, 2015
Expiry Date: Mar 03, 2020
Cancellation Date: May 19, 2022

Cancellation information

Status: Logged out
Reason: 自行鍵入

About this record

Access comprehensive regulatory information for Gerelier neonatal bilirubin (total and unbound) test system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a929c304530244c8dbb179daf9902956 and manufactured by Gerium Medical Ltd.. The authorized representative in Taiwan is WISDOM UNION ENTERPRISE CO., LTD..

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