Data / Medical devices / Italy / RAND S.p.A.
RAND S.p.A.: FDA-registered device maker in MEDOLLA Modena, Italy, 2 510(k) clearances
RAND S.p.A. is registered with the FDA (registration 3003793891) in MEDOLLA Modena, Italy. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 28, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003793891
- Address
- Via Statale 12, 62, MEDOLLA Modena, Italy, 41036
- Owner or operator
- RAND S.p.A. (9063301)
- Roles
- Manufacturer
- First device listed
- May 18, 2012
- Registered through
- 2026
- Brand names listed
- Ch24 round silicone catheter, HANG&GO HT BASIC, Hang&Go PAC, PERFORMER HT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Manufacturer | 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 28, 2016 | K161613 | Hang&Go PAC | LGZ | Substantially Equivalent | Rand S.R.L. | accessdata.fda.gov |
| May 8, 2012 | K120026 | PERFORMER HT/ HANG&GO HT BASIC | LGZ | Substantially Equivalent | Rand S.R.L. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2021 | 87926 | Class II | Terminated | Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120 | The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile. | accessdata.fda.gov |
Compare with other makers
Updated December 28, 2016. 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.