Taiwan FDA registration 5fa78908c65bf51ed1e73444780b162e
EKang blood glucose/cholesterol/heme monitoring system
TW: 易康 血糖/膽固醇/血紅素 監測系統
Taiwan·Risk Class 2·Naohara Biotechnology Co., Ltd.;; Yuxin Biotechnology Co., Ltd·Registered Dec 06, 2017 – Dec 06, 2027ActiveRegistration details
- Analysis ID
- 5fa78908c65bf51ed1e73444780b162e
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- EASY LIFE GREEN TECHNOLOGY CORPORATION
Product details
- Intended Use
- This product is only for in vitro testing, measured with fresh fingertip microvascular whole blood to quantitatively detect blood sugar, cholesterol and heme content. This product can be used by self-testing and healthcare professionals, but is not intended for testing of newborns.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1345 Glucose Test System;; B.7500 Heme analysis of whole blood
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Dec 06, 2017
- Expiry Date
- Dec 06, 2027
About this record
Access comprehensive regulatory information for EKang blood glucose/cholesterol/heme monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5fa78908c65bf51ed1e73444780b162e 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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