Data / Medical devices / Hungary / Meditech KFT.
Meditech KFT.: FDA-registered device maker in Budapest, Hungary, 2 510(k) clearances
Meditech KFT. is registered with the FDA (registration 3003764019) in Budapest, Hungary. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 10, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003764019
- Address
- 24 Mikszath Kalman U, Budapest, Hungary, 1184
- Owner or operator
- MEDITECH KFT. (9046525)
- Roles
- Manufacturer
- First device listed
- March 2, 2008
- Registered through
- 2026
- Brand names listed
- Meditech ABPM-06 (BP6), Meditech Ambulatory Blood Pressure, Model ABPM-05
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| February 10, 2021 | K201332 | Meditech ABPM-06 (BP6) | DXN | Substantially Equivalent | Meditech , Ltd. | accessdata.fda.gov |
| August 3, 2007 | K071960 | MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 | DXN | Substantially Equivalent | Meditech Kft. | accessdata.fda.gov |
Compare with other makers
Updated February 10, 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.