Taiwan FDA registration fe17560e06e3d1dcb4edad9c39309339
"IMMUNOCATCH" Streptococcus pneumoniae (Non-Sterile)
TW: "艾美凱特" 肺炎鏈球菌尿液抗原快速診斷試劑 (未滅菌)
Taiwan·Risk Class 1·MD·EIKEN CHEMICAL CO., LTD.·Registered May 02, 2019 – May 02, 2024ExpiredRegistration details
- Analysis ID
- fe17560e06e3d1dcb4edad9c39309339
- License Form
- Ministry of Health Medical Device Import No. 020392
- Customs Code
- DHA09402039202
Company information
- Manufacturer
- EIKEN CHEMICAL CO., LTD.
- Manufacturer Country
- Japan
- Authorized Representative
- GHOPE INTERNATIONAL BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- Restriction of medical device management methods Streptococcus belongs to the first level identification range of serum reagent (C.3740).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3740 Streptococcus serology
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 02, 2019
- Expiry Date
- May 02, 2024
About this record
Access comprehensive regulatory information for "IMMUNOCATCH" Streptococcus pneumoniae (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 fe17560e06e3d1dcb4edad9c39309339 and manufactured by EIKEN CHEMICAL CO., LTD.. The authorized representative in Taiwan is GHOPE INTERNATIONAL BIOTECHNOLOGY CO., LTD..
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