Taiwan FDA registration fc8258e0a61f78021101a787cca1b8c3
Buddy Tek ST2 Quality Control Fluid
TW: 巴迪鐵克 ST2 品管液
Taiwan·Risk Class 2·Boditech Med Inc.·Registered Dec 25, 2023 – Dec 25, 2028ActiveRegistration details
- Analysis ID
- fc8258e0a61f78021101a787cca1b8c3
- Customs Code
- DHA05603624607
Company information
- Manufacturer
- Boditech Med Inc.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- MEDRICH INSTRUMENT CO., LTD.
Product details
- Intended Use
- This product is used for the quality control of ST2 test reagents. For in vitro diagnostic use only.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Dec 25, 2023
- Expiry Date
- Dec 25, 2028
About this record
Access comprehensive regulatory information for Buddy Tek ST2 Quality Control Fluid in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fc8258e0a61f78021101a787cca1b8c3 and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
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