Vietnam MOH registration 240002999/PCBB-HN

Injection needle assembly for the administration of contrast media

VN: Bộ ống tiêm dùng cho bơm tiêm thuốc đối quang từ

Vietnam·Risk Class TBYT Loại B·Disposable MRI Kit for 65/115 MR Injector System·Bayer Medical Care Inc·Registered Nov 01, 2024

Registration details

Analysis ID: 240002999/PCBB-HN
Submission ID: 000.00.19.H26-241030-0029
Product Type: Disposable MRI Kit for 65/115 MR Injector System
Product Code: SSQK 65/115VS

Company information

Manufacturer: Bayer Medical Care Inc
Product Owner: Bayer Medical Care Inc
Authorized Representative: CÔNG TY CỔ PHẦN ĐẦU TƯ HDN

Technical details

Intended Use: This device is intended for single use in conjunction with the Bayer Fluorescein Injection Pump, which is used to administer the MR contrast agent and the saline solution.

Dates and status

Registration Date: Nov 01, 2024

About this record

Access comprehensive regulatory information for Injection needle assembly for the administration of contrast media 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 240002999/PCBB-HN and manufactured by Bayer Medical Care Inc. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN ĐẦU TƯ HDN.

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