Orlvision GmbH
DE-MF-000013894 · Germany · 35633
Orlvision GmbH is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 18 |
|---|
Most frequent device types declared: FS2, OX2.
Among these devices, 13 are declared active.
Devices declared under this manufacturer
- ATMOS Video Otoskop V2
- ATMOS VideoScope
- FS2
- Nasopharyngoskop PED
- OX2
- Otoskop OX2
- Video Rhino Laryngoskop RS1 – Standard (NTSC)
- Video Rhino Laryngoskop RS1 – Standard (PAL)
- Video Rhino Laryngoskop RSX-P
- Video Rhino Laryngoskop RSX-USB
- Video Rhino Laryngoskop VN-1
- Video Rhino Laryngoskop VN-P
Showing 12 of 18 declared devices.
Catalogue references include 426049941FRLJT, ATMOS Video Otoskop V2, Nasopharyngoskop PED, Otoskop OX2, Video Rhino Laryngoskop RS1 – Standard (PAL), Video Rhino Laryngoskop RSX-USB.
European nomenclature codes declared: Z12021006, C9005, Z12021009.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ORLVISION GMBH (DE) · FDA 3009010438 |
| Devices in EUDAMED | 18 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 18 |
|---|---|
| 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. Orlvision GmbH is registered in the United States but was not found in the Canadian register.