Taiwan FDA registration 4cc24b8c7b6864bc5ab2c8fcb29fcf22
"HiberGene" Nucleic Acid Analyzer (Non-Sterile)
TW: "艾柏基因" 核酸分析儀(未滅菌)
Taiwan·Risk Class 1·MD·HIBERGENE DIAGNOSTICS·Registered May 21, 2019 – May 21, 2024ExpiredRegistration details
- Analysis ID
- 4cc24b8c7b6864bc5ab2c8fcb29fcf22
- License Form
- Ministry of Health Medical Device Import No. 020467
- Customs Code
- DHA09402046707
Company information
- Manufacturer
- HIBERGENE DIAGNOSTICS
- Manufacturer Country
- Ireland
- Authorized Representative
- YOULUM BIOTECHNOLOGY 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)
- A2170 Microchemistry Analyzer for Clinical Use
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 21, 2019
- Expiry Date
- May 21, 2024
About this record
Access comprehensive regulatory information for "HiberGene" Nucleic Acid Analyzer (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 4cc24b8c7b6864bc5ab2c8fcb29fcf22 and manufactured by HIBERGENE DIAGNOSTICS. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY CO., LTD..
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