Vietnam MOH registration 240000549/PCBA-HN

Saline Solution for Nasal Congestion and Dryness

VN: DUNG DỊCH NƯỚC MUỐI ƯU TRƯƠNG GIẢM NGẠT MŨI, KHÔ MŨI

FYSOLINE HYPERTONIC SOLUTION

Vietnam·Risk Class TTBYT Loại A·FYSOLINE HYPERTONIC SOLUTION·LABORATOIRE UNITHER·Registered Apr 05, 2024

Registration details

Analysis ID: 240000549/PCBA-HN
Submission ID: 000.00.19.H26-240322-0018
Product Type: FYSOLINE HYPERTONIC SOLUTION

Company information

Manufacturer: LABORATOIRE UNITHER
Manufacturer Country: FRANCE
Product Owner: GIFRER BARBEZAT
Authorized Representative: CÔNG TY CỔ PHẦN TẬP ĐOÀN DƯỢC PHẨM VÀ THƯƠNG MẠI SOHACO

Technical details

Intended Use: Fysoline ® hypertonic solution is used for infants, children, and adults - Nasal cavity cleaning, preventing nasal mucosa dryness - Hypertonicity helps to relieve nasal congestion in cases of nasal obstruction (nasal congestion/swelling of the nasal mucosa, rhinitis, rhinosinusitis, increased nasal mucus production) - Due to the presence of sodium hyaluronate (a natural component found in some parts of the human body), Fysoline® Hypertonic solution can also be used in cases of nasal mucosa dryness caused by dry air or dust

Dates and status

Registration Date: Apr 05, 2024

About this record

Access comprehensive regulatory information for Saline Solution for Nasal Congestion and Dryness 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 240000549/PCBA-HN and manufactured by LABORATOIRE UNITHER. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN TẬP ĐOÀN DƯỢC PHẨM VÀ THƯƠNG MẠI SOHACO.

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