Taiwan FDA registration 3953d5319340673c546c5c7b5d10048a

Ennegast human immunodeficiency virus test reagent

TW: 恩奈格斯特人類免疫不全病毒檢驗試劑

Taiwan·Risk Class 3·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Registered Nov 23, 2011 – Nov 23, 2021Cancelled

Registration details

Analysis ID: 3953d5319340673c546c5c7b5d10048a
Customs Code: DHA00602274608

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer Country: Germany
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: Enzyme immunoassays were used to legally detect human immunodeficiency virus (HIV) infection, and to detect HIV p24 antigen, human immunoinsufficiency virus types 1 and 2 (HIV1 and HIV2) antibodies, and antibodies against HIV1O group viruses in human serum and blood.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: import

Dates and status

Registration Date: Nov 23, 2011
Expiry Date: Nov 23, 2021
Cancellation Date: Feb 26, 2021

Cancellation information

Status: Logged out
Reason: 自請註銷

About this record

Access comprehensive regulatory information for Ennegast human immunodeficiency virus test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 3953d5319340673c546c5c7b5d10048a and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH. The authorized representative in Taiwan is SIEMENS HEALTHCARE 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.