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MEDICREA™ INTERNATIONAL UNiD™ PATIENT SPECIFIC RODS - HSA Registration DE0510204

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.

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CLASS C
DE0510204
MEDICREA™ INTERNATIONAL UNiD™ PATIENT SPECIFIC RODS
HSA Registration Number: DE0510204
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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)

Device 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 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