Spineart SA
CH-MF-000015664 · Switzerland · PLAN-LES-OUATES
Spineart SA is registered in the European database on medical devices as a manufacturer, with 59 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 59 |
|---|
Among these devices, 59 are declared sterile, 59 reusable.
Authorised representative in the Union: Alpes CN SAS.
Devices declared under this manufacturer
- PERLA NAV. CANNULATED TAP, Ø3.5 (Ø4 SCREW)
- PERLA® TL FIXED PROBE BALL HANDLE
- PERLA® TL NAV PELVIC NAV. CANNULATED TAP
- PERLA® TL NAV PELVIC NAV. LOCKING SCREWDRIVER
- PERLA® TL NAV PELVIC NAV. TAP
- PERLA® TL NAV. SCREWDRIVER, UNIVERSAL
- PERLA® TL PELVIC PROBE SQUARE - CURVED
- PERLA® TL T30 SCREWDRIVER SHAFT
- SCALA® BAYONETED CUP CURETTE SIZE 2 - ANGLED UP
- SCALA® BAYONETED CUP CURETTE SIZE 3 - DOWN
- SCALA® BAYONETED RASP, DUAL-SIDED, STRAIGHT
- SCALA® BAYONETED RING CURETTE 8MM - ANGLED RIGHT
Showing 12 of 59 declared devices.
Catalogue references include HAN-FI BA 50-N, NAV-IN 21 35-N, NAV-IN 33 80-N, NAV-IN 41 15-N, NAV-IN 41 80-N, NAV-IN 41 85-N.
European nomenclature codes declared: Z12011480, L0901, L091001, L091099, S010401, L090401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SPINEART SA (CH) · FDA 3007728266 |
| Devices in EUDAMED | 59 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 59 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Spineart SA is registered in the United States but was not found in the Canadian register.