Data / Medical devices / Hungary / Tesi Product KFT.
Tesi Product KFT.: FDA-registered device maker in Budapest, Hungary, 2 510(k) clearances
Tesi Product KFT. is registered with the FDA (registration 3015751263) in Budapest, Hungary. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 9, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015751263
- Address
- Rozsa utca 38 / A., Budapest, Hungary, 1077
- Owner or operator
- Tesi Product Kft. (10061010)
- Roles
- Exporter to the US
- First device listed
- March 27, 2020
- Registered through
- 2026
- Brand names listed
- Rapid Test Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Reagent, Occult Blood | KHE | 2 | Exporter to the US | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Gas Pressure, Differential | BYR | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| November 9, 2023 | K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) | NGT | Substantially Equivalent | Spm Medicare Pvt. , Ltd. | accessdata.fda.gov |
| August 12, 2004 | K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | KHE | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Saline, Vascular Access Flush
- All makers of Transducer, Gas Pressure, Differential
- All makers of Reagent, Occult Blood
Updated November 9, 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.