Taiwan FDA registration 4d94f472bf86ddf3c15561ddb5c6e6bb
Yili Test GCHb multi-function monitoring system for blood glucose/cholesterol/heme
TW: 易立測GCHb血糖/膽固醇/血紅素多功能監測系統
Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Jun 13, 2011 – Jun 13, 2026ExpiredRegistration details
- Analysis ID
- 4d94f472bf86ddf3c15561ddb5c6e6bb
- Customs Code
- DHY00500330101
Company information
- Manufacturer
- BIOPTIK TECHNOLOGY, INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- BIOPTIK TECHNOLOGY, INC.
Product details
- Intended Use
- This product is only for in vitro testing, measured with fresh fingertip microvascular whole blood to quantify 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. Performance change: This product is only for in vitro testing, and blood glucose and heme content are quantified by measuring fresh fingertip microvascular whole blood. This product is intended for use by healthcare professionals only, but is not intended for testing in newborns.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1345 Glucose Test System
- Import Information
- Domestic
Dates and status
- Registration Date
- Jun 13, 2011
- Expiry Date
- Jun 13, 2026
About this record
Access comprehensive regulatory information for Yili Test GCHb multi-function monitoring system for blood glucose/cholesterol/heme in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4d94f472bf86ddf3c15561ddb5c6e6bb and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is BIOPTIK TECHNOLOGY, INC..
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