EURONDA S.P.A.
IT-MF-000007762 · Italy · Montecchio Precalcino
EURONDA S.P.A. is registered in the European database on medical devices as a manufacturer, with 777 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 724 |
|---|---|
| Class IIb | 53 |
Most frequent device types declared: COTTON ROLLS SIZE 1, E9 INSPECTION® MED S2 24L, EM15 SALIVA EJECTOR, EM19, FACE MASK THE ORIGINAL!.
Among these devices, 54 are declared sterile, 42 active.
Devices declared under this manufacturer
- Absaugkanülen
- DISPOSABLE SALIVA EJECTORS
- E10 18L
- E9 INSPECTION® MED S2 24L
- Kombifolie
- Monoart® Face Mask Protection 3
- Monoart® Face Mask Protection Soft Plus
- Monoart® Face Mask The Original!
- Monoart® Latex Gloves
- Monoart® Rulli di cotone Cotton rolls Watterollen
- Pspipes
- SIRI DISPOSABLE SALIVA EJECTOR
Showing 12 of 777 declared devices.
Catalogue references include 115740, 115XXX, 20220089, 20220091, 217068, 22930111.
European nomenclature codes declared: Q019001, S01020101, T020604, Z12011305, T020199, T01020204.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 777 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 1 |
|---|---|
| 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. EURONDA S.P.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
008/MDR | supplemented | 2026-09-21 |