Vietnam MOH registration 240000583/PCBA-HN

Biovac Direct-Acting Extraction Kit

VN: Bộ dụng cụ hút trực tiếp Biovac

Vietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·United States Endoscopy Group, Inc·Registered Apr 12, 2024

Registration details

Analysis ID: 240000583/PCBA-HN
Submission ID: 000.00.19.H26-240405-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: United States Endoscopy Group, Inc
Manufacturer Country: Theo theo phụ lục
Product Owner: United States Endoscopy Group, Inc
Authorized Representative: CÔNG TY TNHH VẬT TƯ VÀ TRANG THIẾT BỊ Y TẾ HAT-MED VIỆT NAM

Technical details

Intended Use: The BioVac Direct-Acting EndoVac Single-Use Device is indicated for endoscopic retrograde cholangiopancreatography (ERCP), to facilitate the closure and/or fragmentation of blood vessels, the collection of clotted blood or fluid, for example, to remove residual material from the digestive tract through the biopsy/EndoVac channel of the appropriate duodenoscope. It also provides a pathway and conversion for the duodenoscope, and allows for additional irrigation within the duodenoscope when needed.

Dates and status

Registration Date: Apr 12, 2024

About this record

Access comprehensive regulatory information for Biovac Direct-Acting Extraction Kit 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 240000583/PCBA-HN and manufactured by United States Endoscopy Group, Inc. The authorized representative in Vietnam is CÔNG TY TNHH VẬT TƯ VÀ TRANG THIẾT BỊ Y TẾ HAT-MED VIỆT NAM.

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