GLOOR AG
CH-MF-000014214 · Switzerland · Burgdorf
GLOOR AG is registered in the European database on medical devices as a manufacturer, with 2 761 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 248 |
|---|---|
| Class IIb | 1 513 |
Most frequent device types declared: Adapter, Area control unit, BM regulator, Line pressure regulator, Low pressure hose.
Among these devices, 1 521 are declared active.
Authorised representative in the Union: Gloor Medical GmbH.
Devices declared under this manufacturer
- Adapter
- Area control unit
- BM regulator
- High pressure metal hose
- Line pressure regulator
- Low pressure hose
- SWISS optio basic
- SWISS optio clean vac
- SWISS optio clean vent mini
- SWISS optio reduc HP1
- SWISS optio reduc LP
- SWISS optio regflow
Showing 12 of 2 761 declared devices.
Catalogue references include GM2202-0145000, GM2206-2127100, GM2300-2045040, GM4201-0103420, GM8642-002, GX10003/4.
European nomenclature codes declared: Z120309.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Gloor Ltd. (CH) · FDA 3010387558 |
| Devices in EUDAMED | 2 761 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 2 761 |
|---|---|
| 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. GLOOR AG is registered in the United States but was not found in the Canadian register.