ExamVision A/S
DK-MF-000032397 · Denmark · Samsø
ExamVision A/S is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 29 |
|---|
Most frequent device types declared: ExamVision Light System.
Among these devices, 4 are declared active.
Devices declared under this manufacturer
- ExamVision Eyewear Carbonv2
- ExamVision Eyewear Curve
- ExamVision Eyewear Metro
- ExamVision Eyewear Sport v2
- ExamVision Light System Essential One
- ExamVision Light System Power Go
- ExamVision Light System Total Intense (6500 K) LED
- ExamVision Light System Total Pure (5000 K) LED
- ExamVision Loupe System Galilean HD 2.3x
- ExamVision Loupe System Kepler Adavanced v2
- ExamVision Loupe System Kepler Reflekt 4.0x
- Examvision Eyewear Panto
Showing 12 of 29 declared devices.
Catalogue references include Curve, Essential One, KK34, KK76, Powergo, Sportv2.
European nomenclature codes declared: L0316, Q0210030101, Z129004.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EXAMVISION A/S (DK) · FDA 3010600252 |
| Devices in EUDAMED | 29 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 29 |
|---|---|
| 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. ExamVision A/S is registered in the United States but was not found in the Canadian register.