StaClear Low-Particulate Ophthalmic Syringe Receives CE Mark Under New EU MDR Requirements
FOR IMMEDIATE RELEASE
RALEIGH, North Carolina, [July 15, 2025] – StaClear, Inc. today announced that its low-particulate ophthalmic syringes have received CE marking under the updated European Medical Device Regulation (EU MDR), affirming compliance with the latest EU safety, quality, and performance standards.
The StaClear syringe line — Attached Needle, Luer Lock, and Luer Slip — is purpose- built for intravitreal injections commonly used to treat chronic retinal conditions such as neovascular age-related macular degeneration (nAMD). Engineered with retina specialists in mind, StaClear syringes feature a patented lubricant coating that delivers significantly fewer particles than conventional silicone-oil–lubricated syringes.
Key design features include:
Precision dosing and legible markings to enable accurate measurement of small volumes, down to 0.025 mL
Low dead-space design to minimize medication waste, critical for costly anti-VEGF therapies used in hospital and compounding pharmacy settings
Smooth, controlled injection feel, thanks to an elastomer-based piston that maintains sealing integrity during delicate intraocular procedures
Biocompatible, ophthalmic-safe materials meeting EU regulatory and quality standards for drug contact
Strict particle control, in full compliance with USP <789> for ophthalmic solutions
“Achieving CE mark under the new EU MDR is a major milestone for StaClear—and for all retina specialists and pharmacists committed to safer intraocular injections,” said Vinay Sakhrani, Founder and CEO of StaClear. “Our syringe is the result of years of research and development in close collaboration with retina surgeons, pharmacists, and pharmaceutical innovators across the United States, Canada, Australia, Germany, the Netherlands, France, and other EU countries.”
StaClear’s syringe platform is intended for use by hospital pharmacists, outsourcing facilities, compounding pharmacies, retina surgeons, and ophthalmologists. StaClear Syringes are available in unit packs and tray packs designed for streamlined clinical workflows.
Supported by NIH-backed research grants and clinical partnerships with leaders in ophthalmology and compounding pharmacies, StaClear is now preparing for its European commercial launch and seeking distribution and evaluation partners across hospitals, clinics, and retina-focused healthcare providers.
Contact us to order test quantities to evaluate the StaClear syringe for your specific needs.
About StaClear
StaClear, Inc. is a medical device company dedicated to enhancing safety in ophthalmic drug delivery. Its mission is to eliminate preventable risks in intraocular injections by providing single-use, low-particulate syringes. The StaClear syringe line - AttachedNeedle (SC250AN), Luer Slip (SC250LS), and Luer Lock (SC250LL) - is designed for retina specialists, hospital pharmacists, compounding pharmacies, and pharmaceutical partners seeking reliable syringe delivery systems for ophthalmic use.
Contact
Vinay Sakhrani
info@staclear.com
+1-919-838-6716
staclear.com