Medartis AG
CH-MF-000022291 · Switzerland · Basel
Medartis AG is registered in the European database on medical devices as a manufacturer, with 6 915 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 196 |
|---|---|
| Class IIb | 3 719 |
Among these devices, 1 999 are declared sterile, 3 719 implantable, 1 098 reusable.
Authorised representative in the Union: Medartis GmbH.
Devices declared under this manufacturer
- 1.7 CCS Fully Threaded 15mm, 1/Pkg
- 2.2 CCS Short Thread 28/06mm, 1/Pkg
- 2/5 Case Effective Height 144mm
- 3.5 Cortical Screw 60mm, HD15, 1/Pkg
- 4.0 CCS Short Thread 22/05mm, 1/Pkg
- 7.0 CCS Fully Threaded 130mm, 1/Pkg
- Case APTUS Screwdriver, Large
- Implant Case CCS 2.2, 3.0, 120x240mm
- Instrument Case APTUS Clavicle 2.8
- MIDFACE Plate 8 Hole Straight, t0.5
- Sticker Black/Colored \
- Template for A-4950.81
Showing 12 of 6 915 declared devices.
Catalogue references include A-4950.81TP, A-4960.12TP, A-5780.28/1, A-6503, A-6603.013, A-8110.22/1.
European nomenclature codes declared: V9099, P09120603, P09120599, L091099, P09120699, P09120601.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDARTIS AG (CH) · FDA 3003236702 |
| Devices in EUDAMED | 6 915 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 6 915 |
|---|---|
| Found in the U.S. device database | 4 027 |
| Share | 58.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDARTIS AG |
North American profile: Both markets. Medartis AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1809678-1 | supplemented | 2026-12-29 |