Natus Medical Incorporated Natus RetCam Envision - HSA Registration DE0507082
Access comprehensive regulatory information for Natus Medical Incorporated Natus RetCam Envision in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507082 and owned by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK). The device was registered on July 12, 2022.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The RetCam Envision ophthalmic imaging system enables quick, easy capture of wide-field, high-resolution digital images and videos of the eye. It is indicated for the following: - General ophthalmic imaging including retinal, corneal, and external imaging. - Photodocumentation of pediatric ocular diseases, including retinopathy of prematurity (ROP). - Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease), or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease), or threshold ROP (at least 5 contiguous or 8 non- contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) in 35-37 week postmenstrual infants.