Vietnam MOH registration 240002289/PCBB-HN
Cholesterol Concentration in Blood Measurement System
VN: Hệ thống đo nồng độ Cholesterol trong máu
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·VISGENEER, Inc. (Hsinchu Factory)·Registered Sep 04, 2024Registration details
- Analysis ID
- 240002289/PCBB-HN
- Submission ID
- 000.00.19.H26-240831-0006
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- VISGENEER, Inc. (Hsinchu Factory)
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- VISGENEER, Inc. (Hsinchu Factory)
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ NGUYỄN GIA
Technical details
- Intended Use
- It is used to measure the quantitative cholesterol in the total blood of fresh peripheral blood taken from the finger tip. The test is performed outside the body (using in vitro diagnosis). The system is intended for people with hyperlipidemia, who use it at home, or healthcare professionals in a clinical environment, to help monitor the phenomenon of hyperlipidemia.
Dates and status
- Registration Date
- Sep 04, 2024
About this record
Access comprehensive regulatory information for Cholesterol Concentration in Blood Measurement System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002289/PCBB-HN and manufactured by VISGENEER, Inc. (Hsinchu Factory). The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ NGUYỄN GIA.
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