VertiGoggles® Receives SFDA Medical Device Marketing Authorization

19.05.2026
We are proud to announce the successful Medical Device Marketing Authorization (MDMA) approval from the Saudi Food and Drug Authority (SFDA) for the innovative VertiGoggles® system by Shanghai ZEHNIT Medical Technology Co., Ltd.
VertiGoggles® is an advanced binocular infrared diagnostic system designed to support comprehensive vestibular and balance assessment by combining Video Nystagmography (VNG) and true Video Head Impulse Testing (vHIT) within a single integrated platform. The system offers precise 3D tracking, reliable diagnostic data, and a lightweight plug-and-play design that enhances clinical efficiency and patient care.
Through this achievement, UniFusion B.S.C. continues its commitment to supporting global medical device manufacturers in obtaining SFDA regulatory approvals and expanding access to innovative healthcare technologies within the Saudi market.

MDMA Approval for Morningcon Soft Contact Lens

22.01.2026
UniFusion B.S.C is proud to announce the successful issuance of MDMA approval for the Morningcon Soft Contact Lens, a Class C ophthalmic medical device intended for the correction of myopia in the Saudi Arabian market.

Product Details
Manufacturer: Gansu Constar Technology Group Co., Ltd.
Product Name: Morningcon Soft Contact Lens
Classification: Class C Medical Device
Morningcon Soft Contact Lenses are designed to correct refractive errors by modifying the eye’s refractive power, enabling light to focus accurately on the retina. This mechanism enhances visual acuity for individuals with myopia while ensuring comfort, safety, and biocompatibility for regular use.
This regulatory approval marks a significant milestone, reflecting UniFusion B.S.C’s expertise in navigating complex regulatory pathways and its commitment to delivering high-quality, compliant ophthalmic solutions that meet international safety and performance standards.
UniFusion B.S.C remains dedicated to supporting the introduction of innovative medical technologies into the Saudi market and enabling access to reliable vision correction solutions.

Unifusion BSC Achieves MDMA Approval for the World’s First Foldable Capsular Vitreous Body (FCVB)

27.12.2025
Unifusion BSC has achieved a major regulatory milestone by obtaining SFDA Marketing Authorization for the Foldable Capsular Vitreous Body (FCVB), manufactured by Guangzhou Vesber Biotechnology Co., Ltd. The FCVB is the world’s first safe and effective artificial vitreous substitute designed to closely mimic the natural human vitreous body. This innovative technology provides 360-degree retinal support, prevents silicone oil-related complications, preserves intraocular function, and offers a critical new treatment option for patients with severe ocular trauma, silicone oil-dependent eyes, and complex retinal detachments. The approval reflects Unifusion BSC’s commitment to advancing healthcare innovation in the Kingdom in line with Saudi Vision 2030.