Taiwan FDA registration e5384f6ce683510899006d3e68c9597f

"Kaijie" Newmodis BK virus nucleic acid quality control group (unsterilized)

TW: “凱杰” 紐莫帝斯BK病毒核酸品管組 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·SENTINEL CH. S.p.A.·Registered Jul 18, 2023 – Jul 18, 2028Active
Registration details
Analysis ID
e5384f6ce683510899006d3e68c9597f
Customs Code
DHA09402318308
Company information
Manufacturer Country
Italy
Authorized Representative
QIAGEN TAIWAN COMPANY LIMITED
Product details
Intended Use
Limited to the classification and grading management of medical equipment, quality control materials (analytical and non-analytical) (A.1660) the first level identification range.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1660 Quality control materials (analytical and non-analytical)
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Jul 18, 2023
Expiry Date
Jul 18, 2028
About this record

Access comprehensive regulatory information for "Kaijie" Newmodis BK virus nucleic acid quality control group (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number e5384f6ce683510899006d3e68c9597f and manufactured by SENTINEL CH. S.p.A.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

This page provides complete technical specifications, regulatory compliance details. 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.

Free DatabasePowered by Pure Global AI89,000+ Devices