R82 A/S
DK-MF-000000772 · Denmark · Gedved
R82 A/S is registered in the European database on medical devices as a manufacturer, with 160 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 160 |
|---|
Most frequent device types declared: Seating, Standing, Toilet & Bath, Walking.
Devices declared under this manufacturer
- Chilla
- Crocodile
- Flamingo
- Gazelle PS
- High-low:xo
- Kudu
- Manatee
- Penguin
- Rabbit up
- Toucan
- Wombat Living
- x:panda
Showing 12 of 160 declared devices.
Catalogue references include 8622xxx-xx, 880101, 880103, 881121220, 88202x, 891013x-xx.
European nomenclature codes declared: Y180999, Y093399, Y050202, Y122799, Y122199, Y120699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | R82 A/S (DK) · FDA 3001657382 |
| Devices in EUDAMED | 160 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 160 |
|---|---|
| Found in the U.S. device database | 63 |
| Share | 39.4 % |
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. R82 A/S is registered in the United States but was not found in the Canadian register.