Taiwan FDA registration 31a5d0883787117590a1a98e1338d30b
"Orgentec" Mycoplasma Pneumoniae Test (non-sterile)
TW: "歐捷" 肺炎黴漿菌檢測試劑 (未滅菌)
Registration details
- Analysis ID
- 31a5d0883787117590a1a98e1338d30b
- License Form
- Ministry of Health Medical Device Import No. 015069
- Customs Code
- DHA09401506901
Company information
- Manufacturer
- ORGENTEC DIAGNOSTIKA GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- IN FUNG CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Mycoplasma Serological Reagent (C.3375)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3375 Mycoplasma serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 01, 2015
- Expiry Date
- Apr 01, 2025
About this record
Access comprehensive regulatory information for "Orgentec" Mycoplasma Pneumoniae Test (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 31a5d0883787117590a1a98e1338d30b and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..
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