Taiwan FDA registration 64b25503d42c2f56d139b8dcab00b5bf
"Double Eagle" cell cryogenic equipment for in vitro diagnostics (unsterilized)
TW: “雙鷹” 體外診斷用的細胞冷凍設備(未滅菌)
Taiwan·Risk Class 1·IC Biomedical·Registered Jul 11, 2023 – Jul 11, 2028ActiveRegistration details
- Analysis ID
- 64b25503d42c2f56d139b8dcab00b5bf
- Customs Code
- DHA09402318002
Company information
- Manufacturer
- IC Biomedical
- Manufacturer Country
- United States
- Authorized Representative
- DOUBLE EAGLE ENTERPRISE CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management of medical devices, "Cell cryonics equipment and reactants for in vitro diagnosis (B.9225)" Grade 1 identification range.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.9225 Cell freezing equipment and reagents for in vitro diagnostics
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jul 11, 2023
- Expiry Date
- Jul 11, 2028
About this record
Access comprehensive regulatory information for "Double Eagle" cell cryogenic equipment for in vitro diagnostics (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 64b25503d42c2f56d139b8dcab00b5bf and manufactured by IC Biomedical. The authorized representative in Taiwan is DOUBLE EAGLE ENTERPRISE CO., LTD..
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