Vietnam MOH registration 2301305ĐKLH/BYT-HTTB

Radioactive Isotope Injection Pump

VN: Bơm tiêm chất đồng vị phóng xạ

Vietnam·Risk Class TTBYT Loại C·MEDRAD lntego PET Infusion System·Bayer Medical Care Inc.·Registered Oct 11, 2023

Registration details

Analysis ID: 2301305ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220419-0008
Product Type: MEDRAD lntego PET Infusion System
Product Code: INT SYS 200

Company information

Manufacturer: Bayer Medical Care Inc.
Manufacturer Country: UNITED STATES

Technical details

Intended Use: The PET Intego infusion system is designed to deliver precise doses of the radiopharmaceutical 18F-Fluorodeoxyglucose (18F-FDG) or 18F-Natri Fluoride (18F-NaF) and the standard wash solutions used for patients in molecular imaging diagnostic procedures (nuclear medicine). The PET Intego infusion system also provides effective radiation shielding protection for medical personnel from exposure to Fluorine-18 (18F) in nuclear medicine diagnostic procedures.

Dates and status

Registration Date: Oct 11, 2023

About this record

Access comprehensive regulatory information for Radioactive Isotope Injection Pump in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2301305ĐKLH/BYT-HTTB and manufactured by Bayer Medical Care Inc..

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