Taiwan FDA registration 5a69200811954ed085f851a7d80db105
"Novatec" NovaLisa Mycoplasma pneumoniae IgM ELISA (Non-Sterile)
TW: "諾瓦德" 諾瓦莉莎肺炎黴漿菌IgM酵素免疫試驗組 (未滅菌)
Taiwan·Risk Class 1·MD·NOVATEC IMMUNDIAGNOSTICA GMBH·Registered Mar 02, 2016 – Mar 02, 2021ExpiredRegistration details
- Analysis ID
- 5a69200811954ed085f851a7d80db105
- License Form
- Ministry of Health Medical Device Import No. 016215
- Customs Code
- DHA09401621504
Company information
- Manufacturer
- NOVATEC IMMUNDIAGNOSTICA GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- STANDARD MOLECULES INC.
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
- Mar 02, 2016
- Expiry Date
- Mar 02, 2021
About this record
Access comprehensive regulatory information for "Novatec" NovaLisa Mycoplasma pneumoniae IgM ELISA (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 5a69200811954ed085f851a7d80db105 and manufactured by NOVATEC IMMUNDIAGNOSTICA GMBH. The authorized representative in Taiwan is STANDARD MOLECULES INC..
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