A global healthcare company dedicated to improving lives through innovative orthopedic medical devices.
ORTOBRAND INTERNATIONAL was born from the understanding that a medical device is not just a product, but rather a chance for a patient to return to a normal life.
We are a Romanian (EU country) multinational company engaged in research & development, manufacturing, marketing and sales of innovative hyaluronic acid (HA) based orthopedic medical devices for patients suffering from osteoarthritis.
Our team's objective is to reach and help more and more people, by establishing partnerships with specialized companies all over the world.
"A medical device is not just a product, but rather a chance to return to a normal life."
The foundation of every ORTHOFLEX® product.
In 1934, Karl Meyer first announced the discovery of hyaluronic acid — a natural glycosaminoglycan found in all tissues and fluids of animals. Dr. Endre A. Balazs later showed that HA injections in arthritic knees can reduce inflammation and pain — inspiring our mission.
All ORTHOFLEX® products use HA produced via biofermentation — a bacterial fermentation process that produces a higher quality, animal-free hyaluronic acid on an industrial scale. This eliminates any risk of allergic reactions and ensures consistent molecular weight.
Our ORTHOFLEX one® and gel® products use proprietary cross-linking technology — binding HA chains with chondroitin sulfate to create a more durable, longer-lasting viscoelastic network. This increases bio-compatibility and delays cartilage degeneration.
All production complies with Good Manufacturing Practice (GMP) and the European Medical Devices Directive. Products are accredited by the NSAI (National Standards Authority of Ireland) and CE, ISO 13485 certified as Class III medical devices.
All ORTHOFLEX® products carry the CE mark, confirming conformity with the European Medical Devices Directive (93/42/EEC) and permission to be placed on the European market.
Our quality management system is certified to ISO 13485 — the international standard specifically for medical device manufacturers — ensuring consistent design, development, and manufacturing processes.
Production fully complies with GMP guidelines, ensuring every batch of ORTHOFLEX® products meets rigorous safety, quality, and efficacy standards through controlled manufacturing processes.
ORTHOFLEX® products are classified as Class III medical devices — the highest risk category — confirming they meet the strictest safety requirements for implantable and injectable devices.
Explore our ORTHOFLEX® product line or get in touch with our team.