IVD System for quantitative analysis of electrolyte parameters: Potassium, Sodium, Chloride, Calcium, pH
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Caretium Medical Instruments Co., Ltd.·Registered May 28, 2024- Analysis ID
- 240001262/PCBB-HN
- Submission ID
- 000.00.19.H26-240520-0008
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Caretium Medical Instruments Co., Ltd.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Caretium Medical Instruments Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH THƯƠNG MẠI TỔNG HỢP VÀ DỊCH VỤ NHẬT MINH
- Intended Use
- - Automatic Electrolyte Analyzer (Model: XI-1021C): It applies the ISE (Ion Selective Electrode) technology to measure the concentration of potassium (K), sodium (Na), chloride (Cl), calcium (Ca) and pH in human body fluids. - XI-1021-ABW-4-type I: It is used to calibrate the pressure sensor. It is only compatible with the Automatic Electrolyte Analyzer (Model: XI-1021C). - QC Solution: It is used to assess the performance of the Automatic Electrolyte Analyzer.
- Registration Date
- May 28, 2024
Access comprehensive regulatory information for IVD System for quantitative analysis of electrolyte parameters: Potassium, Sodium, Chloride, Calcium, pH in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001262/PCBB-HN and manufactured by Caretium Medical Instruments Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI TỔNG HỢP VÀ DỊCH VỤ NHẬT MINH.
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