Eye drop solution - Vietnam Registration 240002513/PCBB-HCM

Access comprehensive regulatory information for Eye drop solution 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 240002513/PCBB-HCM and manufactured by INDIANA OPHTHALMICS LLP. The authorized representative in Vietnam is CÔNG TY TNHH DƯỢC PHẨM TRANG THIẾT BỊ Y TẾ SONG HIẾU.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including CÔNG TY CỔ PHẦN LIÊN DOANH CÔNG NGHỆ DƯỢC PHẨM VIỆT Ý, DCareme Co., Ltd., and 5 recent registrations in the same category. 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.

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240002513/PCBB-HCM

Registration Details

Vietnam MOH Registration: 240002513/PCBB-HCM

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Device Details

Eye drop solution

VN: Hỗn dịch nhỏ mắt

IO-NATA EYE DROPS

Risk Class TBYT Loại B

Registration Details

Analysis ID

240002513/PCBB-HCM

Submission ID

000.00.19.H29-241029-0025

Product Type

Natamycin Ophthalmic Suspension USP 5%

Technical Details

Intended Use

Supporting the treatment of fungal tarsal conjunctivitis, bacterial conjunctivitis and keratitis caused by sensitive bacteria, including Fusarium solani. Similar to other forms of bacterial keratitis, the initial and maintenance therapy should be determined by clinical diagnosis, and by culture and sensitivity testing of corneal scrapings, as well as by the corneal response to therapy. If possible, the in vitro activity of Natamycin against the pathogenic fungus should be determined. The effectiveness of Natamycin as a monotherapy in fungal endophthalmitis has not been established.