OBERON GmbH Fiber Technologies
DE-MF-000008899 · Germany · Wildau
OBERON GmbH Fiber Technologies is registered in the European database on medical devices as a manufacturer, with 968 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 968 |
|---|
Most frequent device types declared: Disposable Laser Surgery Fibers, non-sterile, Disposable Laser Surgery Fibers, sterile, Reusable Laser Surgery Fibers, non-sterile, Reusable Laser Surgery Fibers, sterile.
Among these devices, 481 are declared sterile, 272 reusable.
Devices declared under this manufacturer
- Laser Surgery Fiber - Bare Fiber 600µm
- Laser Surgery Fiber - Dental Surgery Fiber 200µm
- Laser Surgery Fiber - Fused Radial Emission Fiber 400µm
- Laser Surgery Fiber - General Surgery Fiber 400µm
- Laser Surgery Fiber - Reusable 365 micron laser fiber
- Laser Surgery Fiber - Reusable Surgery Fiber 357µm
- Laser Surgery Fiber - Side Fire Fiber 600µm
- Laser Surgery Fiber 1000µm
- Laser Surgery Fiber 272µm
- Laser Surgery Fiber 365µm
- Laser Surgery Fiber 400µm
- Laser Surgery Fiber 550µm
Showing 12 of 968 declared devices.
Catalogue references include 200054S, 200055N, 210039S, 210119N, 210176N, 220108N.
European nomenclature codes declared: Z12011085.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OBERON GMBH FIBER TECHNOLOGIES (DE) · FDA 3011310540 |
| Devices in EUDAMED | 968 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 36 |
|---|---|
| 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. OBERON GmbH Fiber Technologies is registered in the United States but was not found in the Canadian register.