Singapore HSA registration DE0510204
MEDICREA™ INTERNATIONAL UNiD™ PATIENT SPECIFIC RODS
Singapore·CLASS C·MEDICREA INTERNATIONAL S.A.·Registered January 03, 2025Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0510204
- Registration Date
- January 03, 2025
- Retention Due Date
- January 02, 2026
Product description
The MEDICREA™ INTERNATIONAL S.A. UNiD™ Patient Specific Rods are medical devices designed to contribute to correction and surgical stabilization of the thoracic, lumbar, and sacral spine only. They have to be used with the associated spinal systems (PASS LP or CD Horizon Solera). These devices MUST not be used in the cervical region. These implants are designed to stabilize the spine during normal development of solid bony consolidation. After this period, the presence of the device is no longer strictly required, and removal is possible)
Product Owner
- Short Name
- MEDICREA INTERNATIONAL S.A.
- Address
- 5389 Route de Strasbourg - Vancia, 69140 Rillieux-la-Pape, FRANCE
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- 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 Ti Rod Ø5.5mm UNiD Ti Rod Ø5.5mm -Thin Hexagon UNiD Ti ROD Ø6.0mm UNiD Ti Rod Ø6.0mm -Thin Hexagon UNiD Ti D-ROD Ø6.0 mm
- Model Identifier(s)
- B33125512 B33125522 B33126012 B33126022 B33136012
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 DE0510204 and owned by MEDICREA INTERNATIONAL S.A.. The device was registered on January 03, 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