Vietnam MOH registration 240000372/PCBA-HN

Automated Blood Component Separator

VN: Máy tách thành phần máu tự động

Vietnam·Risk Class TTBYT Loại A·Archimede·Delcon S.r.l.·Registered Mar 12, 2024

Registration details

Analysis ID: 240000372/PCBA-HN
Submission ID: 000.00.19.H26-240217-0004
Product Type: Archimede
Product Code: MOE1504TER

Company information

Manufacturer: Delcon S.r.l.
Manufacturer Country: ITALY
Product Owner: Delcon S.r.l.
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ TERUMO VIỆT NAM

Technical details

Intended Use: ARCHIMEDE is an automated blood component separation device designated to separate blood components from the fully centrifuged blood contained in single-use blood bags. ARCHIMEDE is designated to process blood bags manufactured according to the international standard ISO 3826. In its characteristics, the device can work with any type of blood bag currently available on the market. ARCHIMEDE is designated to work with blood bags of 450/500mL volume; for other types of blood bags, additional accessories are required. The device is designated for use in the blood bank laboratory and is not intended for use in the blood collection process where the donor/patient is still connected to the needle. The device is not designed to come into contact with blood when used correctly.

Dates and status

Registration Date: Mar 12, 2024

About this record

Access comprehensive regulatory information for Automated Blood Component Separator in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000372/PCBA-HN and manufactured by Delcon S.r.l.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ TERUMO VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.