Taiwan FDA registration 5b468297dfdbf99c161f3797adff4500
"Orgentec" Anti-Chlamydia trachomatis IgG (non-sterile)
TW: "歐捷" 砂眼披衣菌IgG抗體試劑 (未滅菌)
Registration details
- Analysis ID
- 5b468297dfdbf99c161f3797adff4500
- License Form
- Ministry of Health Medical Device Import No. 015440
- Customs Code
- DHA09401544006
Company information
- Manufacturer
- ORGENTEC DIAGNOSTIKA GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- IN FUNG CO., LTD.
Product details
- Intended Use
- Limited to the first grade identification range of Chlamydomydia serological reagent (C.3120) for the management of medical devices.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3120 Chlamydia 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-Chlamydia trachomatis IgG (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 5b468297dfdbf99c161f3797adff4500 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.
Free DatabasePowered by Pure Global AI89,000+ Devices