Taiwan FDA registration 82a7618ab1ac8e33c8602f55320b5c32

"Siemens" amylase analysis reagent set

TW: “西門子” 澱粉酶分析試劑組
Taiwan flagTaiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Aug 15, 2018 – Aug 15, 2023Expired
Registration details
Analysis ID
82a7618ab1ac8e33c8602f55320b5c32
Customs Code
DHA05603142202
Company information
Manufacturer Country
United Kingdom;;United States
Authorized Representative
SIEMENS HEALTHCARE LIMITED
Product details
Intended Use
This product is used for in vitro diagnostic use 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
Input;; Contract manufacturing
Dates and status
Registration Date
Aug 15, 2018
Expiry Date
Aug 15, 2023
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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 82a7618ab1ac8e33c8602f55320b5c32 and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD., 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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