Taiwan FDA registration 5ddc51fdf16106ed611c55282c7858c7
Sismer nucleic acid amplification analyzer
TW: 西斯美核酸放大擴增分析儀
Registration details
- Analysis ID
- 5ddc51fdf16106ed611c55282c7858c7
- Customs Code
- DHA04400795307
Company information
- Manufacturer
- SYSMEX CORPORATION, KAKOGAWA FACTORY
- Manufacturer Country
- Japan
- Authorized Representative
- Sandong Instrument Co., Ltd
Product details
- Intended Use
- Limited to the first level identification range of the microchemical analyzer (A.2170) for clinical use of medical equipment management methods.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2170 Microchemical analyzer for clinical use
- Import Information
- import
Dates and status
- Registration Date
- Jul 31, 2009
- Expiry Date
- Jul 31, 2014
- Cancellation Date
- Jul 31, 2018
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for Sismer nucleic acid amplification analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5ddc51fdf16106ed611c55282c7858c7 and manufactured by SYSMEX CORPORATION, KAKOGAWA FACTORY. The authorized representative in Taiwan is Sandong Instrument Co., Ltd.
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