Medos International SARL
CH-MF-000014268 · Switzerland · Le Locle
Medos International SARL is registered in the European database on medical devices as a manufacturer, with 7 113 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 815 |
|---|---|
| Class IIb | 4 287 |
| Class I | 11 |
Most frequent device types declared: Aegis Anterior Lumbar Plate System - Screws, CONFIDENCE Spinal Cement System Needles Instruments, Conduit Lumbar Trials, Cougar LS Instruments for insertion and extraction of osteosynthesis d, EXPEDIUM Spine System Bone Screw.
Among these devices, 1 931 are declared sterile, 4 294 implantable, 2 013 reusable, 1 active.
Authorised representative in the Union: DePuy Ireland UC.
Devices declared under this manufacturer
- AEGIS ANTERIOR LUMBAR PLATE
- CONCORDE LS LATERAL CAGE SYSTEM
- CONDUIT ALIF
- CONFIDENCE SPINAL CEMENT SYSTEM
- EXPEDIUM SFX CROSS CONNECTOR SYSTEM
- EXPEDIUM SPINE SYSTEM
- EXPEDIUM VERSE SPINE SYSTEM
- FASTIN RC w/ORTHOCORD
- Hip Blade Curved
- MITEK CRUCIATE+
- MONARCH SPINE SYSTEM
- MOUNTAINEER OCT SPINAL SYSTEM
Showing 12 of 7 113 declared devices.
Catalogue references include 186132025, 186850020S, 187155021, 242390, 260003, 283904413.
European nomenclature codes declared: P09070302, L091001, P09070301, V0499, Z12130480, L091099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDOS INTERNATIONAL SARL (CH) · FDA 3008114965 |
| Devices in EUDAMED | 7 113 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 7 102 |
|---|---|
| Found in the U.S. device database | 5 947 |
| Share | 83.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDOS INTERNATIONAL SARL |
What it holds in Canada
| Licences on record | 153 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 72 |
| Class 3 devices | 78 |
| Class 4 devices | 3 |
| First licensed | 1998-11-30 |
Licence types: Device Family (62), System (40), Device Group Family (33), Single Device (12).
Licensed under: PERMATAPE SUTURE, CONCORDE BULLET SPINAL SYSTEM TI, CONCORDE CLEAR MIS DISCECTOMY DEVICE, TRUESPAN MENISCAL REPAIR SYSTEM, LATARJET EXPERIENCE INSTABILITY SHOULDER SYSTE, FMS VUE II FLUID MANAGEMENT AND TISSUE DEBRIDE.
North American profile: Both markets. Medos International SARL is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 724423 | supplemented | 2030-12-22 |