Spectro Analytic Irradia AB
SE-MF-000030783 · Sweden · Spånga
Spectro Analytic Irradia AB is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 |
|---|
Most frequent device types declared: MID-LASER, MID-LITE, MIDCARE.
Among these devices, 10 are declared active.
Devices declared under this manufacturer
- MID-LASER
- MID-LITE 6363
- MID-LITE 904
- MIDCARE 635
- MIDCARE 904
- Prob 635-1
- Prob 635-4
- Prob 904-1
- Prob 904-12
- Prob 904-4
Catalogue references include MID-LASER, MID-LITE 6363, MID-LITE 904, MIDCARE 635, Prob 635-1, Prob 904-1.
European nomenclature codes declared: Z120615.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| 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 | 10 |
|---|---|
| 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. Spectro Analytic Irradia AB was not found in either the U.S. or the Canadian register.