Data / Medical devices / Italy / Vacutest Kima SRL
Vacutest Kima SRL: FDA-registered device maker in ARZERGRANDE Padova, Italy, 1 510(k) clearance
Vacutest Kima SRL is registered with the FDA (registration 3010280735) in ARZERGRANDE Padova, Italy. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 14, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010280735
- Address
- Via Dell'industria 12, ARZERGRANDE Padova, Italy, 35020
- Owner or operator
- VACUTEST KIMA Srl (10043026)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 21, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US | accessdata.fda.gov |
| Test, Erythrocyte Sedimentation Rate | JPH | 1 | 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 14, 2021 | K200932 | Blood Collection Needles | FMI | Substantially Equivalent | Vacutest Kima Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Bag, Urine Collection, Leg, For External Use, Sterile
- All makers of Test, Erythrocyte Sedimentation Rate
Updated December 14, 2021. 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.