Taiwan FDA registration 9f7b3a7858d93e77523335affd4b7ea5
“HYPHEN”LA CONTROL PLASMA KIT
TW: “海奉生物醫學” 狼瘡抗凝血因子品管血漿組
Taiwan·Risk Class 2·MD·HYPHEN BioMed·Registered Oct 03, 2019 – Oct 03, 2024ExpiredRegistration details
- Analysis ID
- 9f7b3a7858d93e77523335affd4b7ea5
- License Form
- Ministry of Health Medical Device Import No. 032934
- Customs Code
- DHA05603293408
Company information
- Manufacturer
- HYPHEN BioMed
- Manufacturer Country
- France
- Authorized Representative
- SYSMEX TAIWAN CO., LTD.
Product details
- Intended Use
- This product is a group of freeze-dried quality controlled plasma, including both weakly positive and strongly positive reactions, for the coagulation analysis of lupus anticoagulant factor in vitro.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B5425 Multifunctional equipment for in vitro agglutination research
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 03, 2019
- Expiry Date
- Oct 03, 2024
About this record
Access comprehensive regulatory information for “HYPHEN”LA CONTROL PLASMA KIT in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9f7b3a7858d93e77523335affd4b7ea5 and manufactured by HYPHEN BioMed. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..
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