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Singapore HSA registration DE0510498

MEDICREA™ INTERNATIONAL UNiD™ PATIENT SPECIFIC RODS

Singapore flagSingapore·CLASS C·MEDICREA INTERNATIONAL S.A.S·Registered March 25, 2025
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0510498
Registration Date
March 25, 2025
Retention Due Date
March 24, 2026
Product description
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).
Product Owner
Name
MEDICREA INTERNATIONAL S.A.S
Short Name
MEDICREA INTERNATIONAL S.A.S
Address
5389 Route de Strasbourg - Vancia, 69140 Rillieux-la-Pape, FRANCE
Registrant
Name
MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
UNiD CoCr Rod Ø5.5mm (length: 50-550mm (50mm increment), bending radius: 10-1500mm, bending angle: 0-120°) UNiD CoCr Rod Ø5.5mm -Thin Hexagon (length: 50-550mm (50mm increment), bending radius: 10-1500mm, bending angle: 0-120°) UNiD CoCr ROD Ø6.0mm (length: 50-550mm (50mm increment), bending radius: 10-1500mm, bending angle: 0-120°) UNiD CoCr Rod Ø6.0mm -Thin Hexagon (length: 50-550mm (50mm increment), bending radius: 10-1500mm, bending angle: 0-120°) UNiD CoCr D-ROD Ø6.0 mm (length: 50-550mm (50mm increment), bending radius: 10-1500mm, bending angle: 0-120°)
Model Identifier(s)
B33225512 (length, bending radius, bending angle) B33225522 (length, bending radius, bending angle) B33226012 (length, bending radius, bending angle) B33226022 (length, bending radius, bending angle) B33236012 (length, bending radius, bending angle)
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C