Taiwan FDA registration 165ed5b79af781cf3038e9e13ca40d53
"Albergene" Nucleic Acid Amplification Analyzer (Unsterilized)
TW: “艾柏基因”核酸放大擴增分析儀 (未滅菌)
Taiwan·Risk Class 1·HIBERGENE DIAGNOSTICS;; OptiGene Limited·Registered Oct 23, 2019 – Oct 23, 2024ExpiredRegistration details
- Analysis ID
- 165ed5b79af781cf3038e9e13ca40d53
- Customs Code
- DHA09402097207
Company information
- Manufacturer
- HIBERGENE DIAGNOSTICS;; OptiGene Limited
- Manufacturer Country
- Ireland;;United Kingdom
- Authorized Representative
- YOULUM BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management method of medical equipment, the first level identification range of microchemical analyzer (A.2170) used in clinical use.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2170 Microchemical analyzer for clinical use
- Import Information
- 輸入;; QMS/QSD;; 委託製造
Dates and status
- Registration Date
- Oct 23, 2019
- Expiry Date
- Oct 23, 2024
About this record
Access comprehensive regulatory information for "Albergene" Nucleic Acid Amplification Analyzer (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 165ed5b79af781cf3038e9e13ca40d53 and manufactured by HIBERGENE DIAGNOSTICS;; OptiGene Limited. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY CO., LTD..
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