Taiwan FDA registration 9dbd0a799432a7ee713e5d040ca5e347
“BIOSERV” Anti-Spermatozoa Antibody test (Non-Sterile)
TW: “拜爾思” 精蟲免疫抗體檢驗試劑 (未滅菌)
Taiwan·Risk Class 1·MD·BIOSERV Diagnostics GmbH·Registered Aug 02, 2018 – Aug 02, 2023ExpiredRegistration details
- Analysis ID
- 9dbd0a799432a7ee713e5d040ca5e347
- License Form
- Ministry of Health Medical Device Import No. 019440
- Customs Code
- DHA09401944000
Company information
- Manufacturer
- BIOSERV Diagnostics GmbH
- Manufacturer Country
- Germany
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Human Whole Plasma or Serum Immunoassay System (C.5700)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5700 Human whole plasma or serum immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 02, 2018
- Expiry Date
- Aug 02, 2023
About this record
Access comprehensive regulatory information for “BIOSERV” Anti-Spermatozoa Antibody 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 9dbd0a799432a7ee713e5d040ca5e347 and manufactured by BIOSERV Diagnostics GmbH. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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