Taiwan FDA registration 61f3c9c0942cd59ed7f5295ff38189b8

"Siemens" fructosamine reagent group

TW: “西門子” 果糖胺試劑組
Taiwan flagTaiwan·Risk Class 2·RANDOX LABORATORIES LIMITED;; SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Mar 13, 2014 – Mar 13, 2029Active
Registration details
Analysis ID
61f3c9c0942cd59ed7f5295ff38189b8
Customs Code
DHA05602591602
Company information
Manufacturer Country
United Kingdom;;United States
Authorized Representative
SIEMENS HEALTHCARE LIMITED
Product details
Intended Use
This product is used in conjunction with the ADVIA chemical system (ADVIA 1200, 1650/1800 and 2400) to quantify the concentration of glycosylated protein (fructosamine) in human serum or plasma for in vitro diagnostic use only.
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
Mar 13, 2014
Expiry Date
Mar 13, 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 61f3c9c0942cd59ed7f5295ff38189b8 and manufactured by RANDOX LABORATORIES LIMITED;; 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 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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