Vietnam MOH registration 240000645/PCBB-HCM

Total Bilirubin at the Bedside Measurement System

VN: Hệ thống đo bilirubin toàn phần tại giường

Hệ thống đo bilirubin toàn phần tại giường

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Bilimetrix S.r.l.,·Registered Mar 27, 2024

Registration details

Analysis ID: 240000645/PCBB-HCM
Submission ID: 000.00.19.H29-240320-0008
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Bilimetrix S.r.l.,
Manufacturer Country: Theo theo phụ lục
Product Owner: Bilimetrix S.r.l.,
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ DMED

Technical details

Intended Use: Bilistick® is a point-of-care diagnostic instrument for the determination of total serum bilirubin (TSB) concentration in the blood of newborns. The determination of TSB concentration using the Bilistick® system does not require the use of reagents, thus simplifying the measurement process. After the sample is loaded, the concentration of bilirubin is calculated and displayed within a few minutes. The Bilistick® system allows for the determination of bilirubin concentration in the range from 1 mg/dL to 40 mg/dL (17 to 684 µmol/L) with accuracy comparable to that of traditional clinical laboratory instruments.

Dates and status

Registration Date: Mar 27, 2024

About this record

Access comprehensive regulatory information for Total Bilirubin at the Bedside Measurement System 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 240000645/PCBB-HCM and manufactured by Bilimetrix S.r.l.,. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ DMED.

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