Qualiteam s.r.l.
IT-MF-000026616 · Italy · Burolo
Qualiteam s.r.l. is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 80 |
|---|
Most frequent device types declared: AxillaPad, Calla Ear Band, Calla Eye & Nose Band, DUO LVAD Driveline Support Binder, QualiBelly.
Devices declared under this manufacturer
- AxillaPad
- Calla Eye & Nose Band (Lace White)
- DUO LVAD Driveline Support Binder (S)
- QualiBelly (Extra Large)
- QualiBelly Advanced (40cm XL)
- QualiBelly Advanced (Extra Large)
- QualiBelly Advanced (Small)
- QualiBra Advanced (4XL - PLUS)
- QualiBra Advanced (XXXL - PLUS)
- QualiBreath (size L)
- QualiMaternity Maternity and Lumbar Support binder
- Thor (4XL)
Showing 12 of 80 declared devices.
Catalogue references include DUO-S, QADV-4XL PLUS, QADV-XXXL PLUS, QBAX, QLY20-XL, QM10S.
European nomenclature codes declared: Y060307, Y060499, M030499, V080399, M9001, C030180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | QUALITEAM S.R.L. (IT) · FDA 3003905499 |
| Devices in EUDAMED | 80 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 80 |
|---|---|
| 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. Qualiteam s.r.l. is registered in the United States but was not found in the Canadian register.