Taiwan FDA registration dc3bc763c9cbda9ed905075a1ec693a3

VITROS Immunodiagnostic Products Insulin Reagent Pack (Non-Sterile)

TW: 維特司胰島素免疫檢測試劑組(未滅菌)

Taiwan·Risk Class 1·MD·ORTHO-CLINICAL DIAGNOSTICS·Registered Sep 26, 2020 – Sep 26, 2025Expired

Registration details

Analysis ID: dc3bc763c9cbda9ed905075a1ec693a3
License Form: Ministry of Health Medical Device Import No. 021991
Customs Code: DHA09402199103

Company information

Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Manufacturer Country: United Kingdom
Authorized Representative: DKSH TAIWAN LTD.

Product details

Intended Use: Limited to the first level identification range of the immunoresponsive insulin test system (A.1405) of the management method for medical devices.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1405 Immunoresponsive Insulin Test System
Import Information: Imported from abroad

Dates and status

Registration Date: Sep 26, 2020
Expiry Date: Sep 26, 2025

About this record

Access comprehensive regulatory information for VITROS Immunodiagnostic Products Insulin Reagent Pack (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number dc3bc763c9cbda9ed905075a1ec693a3 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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.