Taiwan FDA registration b092a7e2d16e73ce8804f2536889110b
"OMEGA" VISITECT LEPTOSPIROSIS (Non-Sterile)
TW: "奧米加" 鉤端螺旋體快速檢驗試劑 (未滅菌)
Registration details
- Analysis ID
- b092a7e2d16e73ce8804f2536889110b
- License Form
- Ministry of Health Medical Device Import No. 019167
- Customs Code
- DHA09401916708
Company information
- Manufacturer
- OMEGA DIAGNOSTICS LTD.
- Manufacturer Country
- United Kingdom
- Authorized Representative
- EUGENE-CHEN CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of the medical device management measures "Leptospira sera reagent (C.3350)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3350 Leptospira serology
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 11, 2018
- Expiry Date
- Jun 11, 2023
About this record
Access comprehensive regulatory information for "OMEGA" VISITECT LEPTOSPIROSIS (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 b092a7e2d16e73ce8804f2536889110b and manufactured by OMEGA DIAGNOSTICS LTD.. The authorized representative in Taiwan is EUGENE-CHEN 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