Taiwan FDA registration 3edfb12d4cc64ddc03e5640b0e2258e8

"Orgentec" Anti-EBV (ZEBRA) IgM (non-sterile)

TW: "歐捷" EB病毒(ZEBRA) IgM抗體試劑 (未滅菌)

Taiwan·Risk Class 1·MD·ORGENTEC DIAGNOSTIKA GMBH·Registered Jul 08, 2015 – Jul 08, 2025Expired

Registration details

Analysis ID: 3edfb12d4cc64ddc03e5640b0e2258e8
License Form: Ministry of Health Medical Device Import No. 015445
Customs Code: DHA09401544503

Company information

Manufacturer: ORGENTEC DIAGNOSTIKA GMBH
Manufacturer Country: Germany
Authorized Representative: IN FUNG CO., LTD.

Product details

Intended Use: Limited to the first level identification range of "Epstein-Barr virus serum reagent (C.3235)" of the Measures for the Administration of Medical Devices.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3235 Epstein-Barr virus serum reagent
Import Information: Imported from abroad

Dates and status

Registration Date: Jul 08, 2015
Expiry Date: Jul 08, 2025

About this record

Access comprehensive regulatory information for "Orgentec" Anti-EBV (ZEBRA) IgM (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 3edfb12d4cc64ddc03e5640b0e2258e8 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., 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.