Taiwan FDA registration 30d217fdd689b9e07d2661b9eddb380f

Premier Hb9210 Glycated hemoglobin assay

TW: “尊爵” 醣化血色素分析試劑組

Taiwan·Risk Class 2·MD·Trinity Biotech (Primus Corporation dba Trinity Biotech)·Registered Apr 09, 2015 – Apr 09, 2025Expired

Registration details

Analysis ID: 30d217fdd689b9e07d2661b9eddb380f
License Form: Ministry of Health Medical Device Import No. 027200
Customs Code: DHA05602720008

Company information

Manufacturer: Trinity Biotech (Primus Corporation dba Trinity Biotech)
Manufacturer Country: United States
Authorized Representative: PROGRESSIVE GROUP INC.

Product details

Intended Use: For details, it is Chinese approved copy of the imitation order. Performance (discretionary) changes: as detailed in Chinese label, instruction manual or package approved version.
Product Type (Level 1): B Hematology and pathology devices
Product Type (Level 2): B7470 Glycosylated heme analysis
Import Information: Imported from abroad

Dates and status

Registration Date: Apr 09, 2015
Expiry Date: Apr 09, 2025

About this record

Access comprehensive regulatory information for Premier Hb9210 Glycated hemoglobin assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 30d217fdd689b9e07d2661b9eddb380f and manufactured by Trinity Biotech (Primus Corporation dba Trinity Biotech). The authorized representative in Taiwan is PROGRESSIVE GROUP INC..

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