Sibbo Medical Devices Oy
FI-MF-000035896 · Finland · Helsinki
Sibbo Medical Devices Oy is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: Loupe, Otoscope.
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- Digital EarPenguin
- EarPenguin
- EarPuffin
- Sibbo Cyclops
- Sibbo Loupe
- Sibbo MD App
- Sibbo MD Monitor
- Sibbo Periscope
- Sibbo Rhinoscope
Catalogue references include APP-001-HV, DEP-001-H, EP-001-H, SC-001-H, SL-001-H, SM-001-HV.
European nomenclature codes declared: Z12021007, Z12021004, Z12021008, Z12149006, Z12120124.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| Country of registration | Finland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| 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: Neither register. Sibbo Medical Devices Oy was not found in either the U.S. or the Canadian register.