Taiwan FDA registration fc830f9ce2ad95e99323a9341979f28f
"Kabi" Louvre fully automatic cell processing system
TW: “卡比” 羅浮全自動細胞處理系統
Taiwan·Risk Class 2·FRESENIUS KABI WARRENDALE;; Fresenius Kabi AG·Registered Apr 14, 2021 – Apr 14, 2026ExpiredRegistration details
- Analysis ID
- fc830f9ce2ad95e99323a9341979f28f
- Customs Code
- DHA05603439300
Company information
- Manufacturer
- FRESENIUS KABI WARRENDALE;; Fresenius Kabi AG
- Manufacturer Country
- United States;;Germany
- Authorized Representative
- FRESENIUS KABI TAIWAN LIMITED
Product details
- Intended Use
- This product is a desktop machine that can automatically clean cells. This system removes the supernatant by using non-micronized rotating membrane filtration for the separation and preparation of blood components. The system consists of a LOVO instrument and a LOVO single-use kit (not included in this product).
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.9245 Automated hemocytoseparator
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Apr 14, 2021
- Expiry Date
- Apr 14, 2026
About this record
Access comprehensive regulatory information for "Kabi" Louvre fully automatic cell processing system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fc830f9ce2ad95e99323a9341979f28f and manufactured by FRESENIUS KABI WARRENDALE;; Fresenius Kabi AG. The authorized representative in Taiwan is FRESENIUS KABI TAIWAN LIMITED.
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