Taiwan FDA registration 099b8f7ac3492ca34498275f1c8621df
"SD Biosensor" Legionella (Non-Sterile)
TW: "艾司迪堡" 退伍軍人肺炎尿液抗原快速診斷試劑 (未滅菌)
Registration details
- Analysis ID
- 099b8f7ac3492ca34498275f1c8621df
- License Form
- Ministry of Health Medical Device Import No. 017774
- Customs Code
- DHA09401777406
Company information
- Manufacturer
- SD BIOSENSOR, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- JOLEX INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Limit the management method of medical equipment Haemophilus serogenus (C.3300) first level identification range.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3300 Haemophilus serology
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 28, 2017
- Expiry Date
- Apr 28, 2022
About this record
Access comprehensive regulatory information for "SD Biosensor" Legionella (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 099b8f7ac3492ca34498275f1c8621df and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is JOLEX INTERNATIONAL CO., LTD..
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