Taiwan FDA registration 0380e7f2a3d90910d65d4d6cdc806191
Ekang Blood Ketone Monitoring System (Unsterilized)
TW: 易康 血酮 監測系統 (未滅菌)
Taiwan·Risk Class 1·Naohara Biotechnology Co., Ltd.;; Yuxin Biotechnology Co., Ltd·Registered Mar 25, 2022 – Mar 25, 2027ActiveRegistration details
- Analysis ID
- 0380e7f2a3d90910d65d4d6cdc806191
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- EASY LIFE GREEN TECHNOLOGY CORPORATION
Product details
- Intended Use
- Limited to the classification and grading management of medical equipment "Ketone (non-quantitative) test system (A.1435)" first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1435 Ketone (non-quantitative) testing system
- Import Information
- QMS/QSD;; 委託製造;; 國產
Dates and status
- Registration Date
- Mar 25, 2022
- Expiry Date
- Mar 25, 2027
About this record
Access comprehensive regulatory information for Ekang Blood Ketone Monitoring System (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0380e7f2a3d90910d65d4d6cdc806191 and manufactured by Naohara Biotechnology Co., Ltd.;; Yuxin Biotechnology Co., Ltd. The authorized representative in Taiwan is EASY LIFE GREEN TECHNOLOGY CORPORATION.
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