STEELCO S.P.A.
IT-MF-000029689 · Italy · RIESE PIO X
STEELCO S.P.A. is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|---|
| Class IIb | 19 |
Most frequent device types declared: DRYERS, DS 1000 3S, ETD Mini, EW 1, Endoscope Washer.
Among these devices, 30 are declared active.
Devices declared under this manufacturer
- DRYERS
- DS 1000 3S
- DS 610 SL G2
- Dryers
- ETD Mini
- EW 1
- Endoscope Washer
- STEAM STERILIZING UNIT
- Storage of Endoscope
- TW 3000/2
- Ultrasonic Cleaning System
- VS 8/2
Showing 12 of 31 declared devices.
Catalogue references include 9968024, 9979004, AD 400/1, AD 400/2, ED 200/1 S, ED 200/2 S, ED 200/3 S, ED 200/4 S, ED 200/1, ED 200/2, ED 200/3, ED 200/4, ED 250/1, ED 250/2, ED 250/3, ED 250/4.
European nomenclature codes declared: Z12011301, Z12011314, Z12011304, Z12011302, Z12011311, V9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STEELCO S.P.A. (IT) · FDA 3005544459 |
| Devices in EUDAMED | 31 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | STEELCO S.P.A. |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2015-04-07 |
Licence types: Device Family (3).
Licensed under: DECONTAMINATION CLEANERS, WASHER DISINFECTORS, FLUSHER DISINFECTOR.
North American profile: Both markets. STEELCO S.P.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
065/MDR | amended | 2027-12-22 |