Data / Medical devices / Italy / Steelco S.P.A.
Steelco S.P.A.: FDA-registered device maker in Riese Pio X Treviso, Italy, 1 510(k) clearance
Steelco S.P.A. is registered with the FDA (registration 3005544459) in Riese Pio X Treviso, Italy. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 2, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005544459
- FEI number
- 3008241044
- Address
- Via Balegante, 27, Riese Pio X Treviso, Italy, 31039
- Owner or operator
- STEELCO S.P.A. (10026042)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 3, 2008
- Registered through
- 2026
- Brand names listed
- AD 400, BP 100, DS 1000, DS 50, DS 500, DS 600, DS 600 G2, DS 610 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Specification developer | accessdata.fda.gov |
| Unit, Drying | JRJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Washer Of Body Waste Receptacles | FLH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 2, 2023 | K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | FLE | Substantially Equivalent | Steelco S.P.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleaner, Ultrasonic, Medical Instrument
- All makers of Disinfector, Medical Devices
- All makers of Unit, Drying
- All makers of Washer Of Body Waste Receptacles
- All makers of Sterilizer, Steam
Updated February 2, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.