Taiwan FDA registration b140c90bec8265c7fda03a13561fe2c3

"Siemens" fructosamine reagent group

TW: “西門子” 果糖胺試劑組
Taiwan flagTaiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Jan 07, 2019 – Jan 07, 2029Active
Registration details
Analysis ID
b140c90bec8265c7fda03a13561fe2c3
Customs Code
DHA05603200504
Company information
Manufacturer Country
United Kingdom;;United States
Authorized Representative
SIEMENS HEALTHCARE LIMITED
Product details
Intended Use
This product is used for in vitro diagnostics, and needs to be used with Atellica CH Analyzer to quantitatively detect glycated proteins (fructosamine) in human serum and plasma (heparin lithium, EDTA potassium salt).
Product Type (Level 1)
B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1150 calibration;; B.7470 Analysis of glycosylated hemoglobin
Import Information
Input;; Contract manufacturing
Dates and status
Registration Date
Jan 07, 2019
Expiry Date
Jan 07, 2029
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About this record

Access comprehensive regulatory information for "Siemens" fructosamine reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b140c90bec8265c7fda03a13561fe2c3 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 RANDOX LABORATORIES LIMITED;; 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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