Taiwan FDA registration 4fe13d345a464e27b7368bc4dac04c16

"Jerry" Neonatal Bilirubin (Total & Unconjugated) Test System (Non-sterile)

TW: "傑瑞" 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 Oct 22, 2024 – Oct 22, 2029Active

Registration details

Analysis ID: 4fe13d345a464e27b7368bc4dac04c16
Customs Code: DHA09402364000

Company information

Manufacturer: Gerium Medical Ltd.
Manufacturer Country: Israel
Authorized Representative: BIOSYSTEMS INC.

Product details

Intended Use: It is limited to the first level of identification scope of the "Neonatal Bilirubin (Total and Unbound) Test System (A.1113)" 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): A.1113 Neonatal bilirubin (total and unconjugated) test system
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Oct 22, 2024
Expiry Date: Oct 22, 2029

About this record

Access comprehensive regulatory information for "Jerry" Neonatal Bilirubin (Total & Unconjugated) Test System (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 4fe13d345a464e27b7368bc4dac04c16 and manufactured by Gerium Medical Ltd.. The authorized representative in Taiwan is BIOSYSTEMS INC..

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