Taiwan FDA registration 0d3b4bba7df41aaffa39380bddc67d73
"Siemens Atellica" Anti-streptolysin O (ASO) Reagent (Non-Sterile)
TW: "西門子" 抗鏈球菌溶血素O試劑 (未滅菌)
Registration details
- Analysis ID
- 0d3b4bba7df41aaffa39380bddc67d73
- License Form
- Ministry of Health Medical Device Import No. 018498
- Customs Code
- DHA09401849800
Company information
- Manufacturer
- RANDOX LABORATORIES LIMITED
- Manufacturer Country
- United Kingdom
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- Limited to the management of medical devices: Streptococcus is an extracellular enzyme reagent (C.3720) in the first grade identification range.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3720 Streptococcus is an extracellular enzyme reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 14, 2017
- Expiry Date
- Nov 14, 2027
About this record
Access comprehensive regulatory information for "Siemens Atellica" Anti-streptolysin O (ASO) Reagent (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 0d3b4bba7df41aaffa39380bddc67d73 and manufactured by RANDOX LABORATORIES LIMITED. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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