Data / Medical devices / Italy / Hydra SRL
Hydra SRL: FDA-registered device maker in Mirandola Modena, Italy, 1 510(k) clearance
Hydra SRL is registered with the FDA (registration 3011707889) in Mirandola Modena, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011707889
- Address
- Via Savonarola 4, Mirandola Modena, Italy, 41037
- Owner or operator
- Hydra Srl (10049329)
- Roles
- Specification developer
- First device listed
- May 12, 2015
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | 2 | Specification developer | accessdata.fda.gov |
| System, Suction, Lipoplasty | MUU | 2 | 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 |
|---|---|---|---|---|---|---|
| December 22, 2014 | K142682 | The Lipogems System | MUU | Substantially Equivalent | Lipogems International Spa | accessdata.fda.gov |
Compare with other makers
- All makers of Lipoaspirate Washing System For Aesthetic Body Contouring
- All makers of System, Suction, Lipoplasty
Updated December 22, 2014. 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.