Taiwan FDA registration 63ea93b7e075dedc1c0c47d1d30c1937

"Siemens" amylase analysis reagent set

TW: “西門子” 澱粉酶分析試劑組
Taiwan flagTaiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.·Registered Oct 26, 2020 – Oct 26, 2025Expired
Registration details
Analysis ID
63ea93b7e075dedc1c0c47d1d30c1937
Customs Code
DHA05603369304
Company information
Manufacturer Country
United Kingdom;;United States
Authorized Representative
SIEMENS HEALTHCARE LIMITED
Product details
Intended Use
This product is used in vitro diagnostics with Atellica CH Analyzer to quantitatively detect amylase activity in human serum, plasma (heparin lithium) and urine.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1070 澱粉酶試驗系統
Import Information
QMS/QSD;; 輸入;; 委託製造
Dates and status
Registration Date
Oct 26, 2020
Expiry Date
Oct 26, 2025
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About this record

Access comprehensive regulatory information for "Siemens" amylase analysis reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 63ea93b7e075dedc1c0c47d1d30c1937 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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