MEDICREA™ INTERNATIONAL UNiD™ PATIENT SPECIFIC RODS - HSA Registration DE0510498
Access comprehensive regulatory information for MEDICREA™ INTERNATIONAL UNiD™ PATIENT SPECIFIC RODS in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510498 and owned by MEDICREA INTERNATIONAL S.A.S. The device was registered on March 25, 2025.
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 MEDICREA™ INTERNATIONAL S.A. UNiD™ Patient Specific Rods, when used with the different vertebral anchorage components of the associated spinal systems (Pass LP or CD Horizon Solera), are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: 1. Degenerative disc diseases. 2. Trauma (Fractures, dislocation). 3. Spinal stenosis. 4. Spondylolisthesis. 5. Spinal deformations or curvature such as scoliosis, kyphosis and/or lordosis, or adolescent idiopathic scoliosis. 6. Loss of stability due to tumor. 7. Failed previous fusion (Pseudarthrosis).