Taiwan FDA registration 8de1cefcacf08c0be377db4742c40747

"Siemens" prealbumin test reagent (non-sterilized)

TW: "西門子"前白蛋白檢驗試劑(未滅菌)

Taiwan·Risk Class 1·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Mar 20, 2024 – Mar 20, 2029Active

Registration details

Analysis ID: 8de1cefcacf08c0be377db4742c40747
Customs Code: DHA09402342608

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Country: United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: It is limited to the first-level identification scope of the "Prealbumin Immunoassay System (C.5060)" of the Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5060 Prealbumin immunoassay system
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Mar 20, 2024
Expiry Date: Mar 20, 2029

About this record

Access comprehensive regulatory information for "Siemens" prealbumin test reagent (non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8de1cefcacf08c0be377db4742c40747 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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