Leica Microsystems (Schweiz) AG
CH-MF-000021185 · Switzerland · Heerbrugg
Leica Microsystems (Schweiz) AG is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 52 |
|---|
Most frequent device types declared: ARveo 8, ARveo 8x, FL400 for M530, M320, M530 OHX.
Among these devices, 49 are declared active.
Authorised representative in the Union: Leica Microsystems CMS GmbH.
Devices declared under this manufacturer
- ARveo 8x
- M320 C12
- M320 F12
- M320 Optics Carrier incl. Swing Arm, inclined C/W 12
- M320 Optics Carrier incl. Swing Arm, perpendicular C/W 12
- M320 TC12
- M320 TP12
- M530 OHX Type J
- PROVEO 8
- PROVEO 8 - Optics Carrier
- PROVIDO 8
- PROvido (Premium)
Showing 12 of 52 declared devices.
Catalogue references include 10448434, 10448537, 10448808, 10448872, 10448950, 10449125.
European nomenclature codes declared: Z12011101, Z12011199, Z1201118099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LEICA MICROSYSTEMS (SCHWEIZ) AG (CH) · FDA 3003974370 |
| Devices in EUDAMED | 52 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 52 |
|---|---|
| Found in the U.S. device database | 43 |
| Share | 82.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LEICA MICROSYSTEMS (SCHWEIZ) AG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2020-07-27 |
Licence types: Single Device (3), Device Family (1).
Licensed under: GLOW800, LEICA FL800 ULT, LEICA FL560 FOR M530, GLOW400.
North American profile: Both markets. Leica Microsystems (Schweiz) AG is registered in both the United States and Canada.