Iromed Group CF X-Linker - HSA Registration DE0509994
Access comprehensive regulatory information for Iromed Group CF X-Linker in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509994 and owned by Iromed Group S.R.L.. The device was registered on October 30, 2024.
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 CF-X LINKER device is indicated in the conservative treatment of keratoconus and all ectatic corneal diseases. In particular, it is indicated: a. in all ectatic corneal diseases, both genetic and iatrogenic, such as keratoconus and/or marginal pellucid degeneration, a disease characterised by progressive swelling of the cornea and an abnormal laxity of the corneal parenchyma due to reduced cohesion of the collagen lamellae of which it is composed. b. in all ectatic diseases of the cornea caused by infections, trauma, post-LASIK refractive surgery and/or post-photorefractive keratectomy (PRK) and/or radial keratotomy (RK). c. infections in diseases of the cornea, such as keratitis, and generally all situations that require cross-linking.