We are so glad to announce that Singclean Medical has got the MDR certificate of Viscoelastic Solution for Ophthalmic Surgery!
It is supposed to be the first MDR certificate of OVD in China.
Since May 26, 2021, the CE certification of medical devices has officially entered the MDR era from MDD.
The new MDR places more stringent requirements on medical device companies, so it’s not easy to get the certificate. You will need a strong regulatory affairs (RA) team. The MDR is four times the size of the MDD and has an emphasis on device safety. Medical device manufacturers need to update clinical data, technical documentation, and labeling for all devices and make sure the device is designed, manufactured, and tracked in accordance with the MDR’s requirements.
What’s Singclean® OVD?
Singclean® is a high molecular weight (between 1,000,000~2,600,000) fraction of sodium hyaluronate (1.5% total weight) dissolved in a sodium phosphate buffer. The osmotic pressure of Singclean® is nominally 270 mOsmol/kg ~ 350mOsmol/kg.
15mg/mL: 0.5mL, 0.75mL, 1.0mL, 2.0mL
Singclean® OVD is intended to aid anterior or posterior segment ophthalmic surgery, including:
·Cataract extraction with/without implantation of intraocular lens;
·Corneal transplant surgery;
·Glaucoma filtering surgery;
·Secondary lens implantation.
The Function of Singclean® OVD
The main function of Singclean® ophthalmic viscosurgical device is to protect the endothelial cells at each step of the ophthalmic surgery. It is a cohesive OVD. This type of OVDs are very good at space creation and maintenance due to their higher viscosity and molecular weight. Therefore, they can minimize the interaction between instrument and tissue and absorb shock during phacoemulsification. This way, they can protect the delicate tissues in the anterior chamber.
Singclean® OVD Advantages
1. Effective: high molecular weight to achieve excellent chamber maintenance
2. Reduce eye irritation: close to tear osmolality: 300mOsm/kg
3. Safe: normal pH range in the human eye ranges from 7.0 to 7.4 (very neutral)
4. Biocompatible: do not contain animal tissue
5. Easy to use: don’t have to store in refrigerator
Back in 2011, Singclean Medical has already got the CE certification of Singclean® Sterile Viscoelastic Solution for Ophthalmic Surgery which then becomes one of our most popular products. Over the past 11 years, Singclean® ophthalmic viscoelastic device has been sold to over 60 countries and regions and received lots of positive feedback.
In the future, Singclean Medical will continue to focus on the innovation of medical sodium hyaluronate products and help more people live healthier.