Disentis AB
SE-MF-000050466 · Sweden · Hisings Backa
Disentis AB is registered in the European database on medical devices as a manufacturer, with 109 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 109 |
|---|
Most frequent device types declared: 007 Waye Readers Sun Demi Brown Black / Sun lens 10, WR0002, WR0003, WR0004, WR0005.
Devices declared under this manufacturer
- 001 Waye Readers
- 002 Waye Readers Demi Brown 30
- 004 Waye Readers Matt Demi Brown / Reader 15
- 004 Waye Readers Shiny Black 10
- 004 Waye Readers Shiny Black 20
- 005 Waye Readers Demi Grey 15
- 007 Waye Readers Sun Demi Brown Black / Sun lens 25
- 007 Waye Readers Sun Demi Brown Black / Sun lens 35
- 011 Waye Readers Gradient Brown / Readers 25
- 011 Waye Readers Gradient Brown / Readers 35
- 012 Waye Readers MilkyTran Beige / Readers 20
- 014 Waye Readers transparent dark brown +1,5
Showing 12 of 109 declared devices.
Catalogue references include WR0001R001-25, WR0002R002-30, WR0004R001-10, WR0005R002-15, WR0007R001-35, WR0011R001-35.
European nomenclature codes declared: Q0210030102, Q0210030101, Q0210030103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 109 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 109 |
|---|---|
| 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. Disentis AB was not found in either the U.S. or the Canadian register.