Data / Medical devices / Hungary / Emd Endoszkop Muszer Gyarto Es Kereskedelmi KFT.
Emd Endoszkop Muszer Gyarto Es Kereskedelmi KFT.: FDA-registered device maker in Debrecen Hajdu-Bihar, Hungary, 1 510(k) clearance
Emd Endoszkop Muszer Gyarto Es Kereskedelmi KFT. is registered with the FDA (registration 3014724561) in Debrecen Hajdu-Bihar, Hungary. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014724561
- Address
- Bartok Bela Str. 113/B, Debrecen Hajdu-Bihar, Hungary, 4031
- Owner or operator
- EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft. (10090499)
- Roles
- Manufacturer
- First device listed
- April 5, 2024
- Registered through
- 2026
- Brand names listed
- NeuroLine Disposable Cranial Perforator with Hudson-end
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | 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 |
|---|---|---|---|---|---|---|
| June 20, 2022 | K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | HBF | Substantially Equivalent | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | accessdata.fda.gov |
Compare with other makers
Updated June 20, 2022. 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.