Data / Medical devices / Hungary / Safegard Medical (hungary), Ltd.
Safegard Medical (hungary), Ltd.: FDA-registered device maker in FARKASLYUK Borsod-Abauj-Zemplen, Hungary, 3 510(k) clearances
Safegard Medical (hungary), Ltd. is registered with the FDA (registration 9616482) in FARKASLYUK Borsod-Abauj-Zemplen, Hungary. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 24, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616482
- FEI number
- 3003188701
- Address
- Joszerencset Ter 15, FARKASLYUK Borsod-Abauj-Zemplen, Hungary, H-3608
- Owner or operator
- NUMAN HOLDING LTD (9039987)
- Roles
- Manufacturer
- First device listed
- October 12, 2007
- Registered through
- 2026
- Brand names listed
- SECUREGARD Retractable Safety Syringe, SOLOGARD Locking Plus Syringe with Needle, SOLOGARD Two Parts Syringe Without Needle, Securegard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 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 |
|---|---|---|---|---|---|---|
| October 24, 2001 | K012121 | SECUREGUARD RETRACTABLE SAFETY SYRINGE | MEG | Substantially Equivalent | Safegard Medical Products, Inc. | accessdata.fda.gov |
| October 1, 2001 | K012283 | SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE | FMI | Substantially Equivalent | Safegard Medical Products, Inc. | accessdata.fda.gov |
| March 17, 2000 | K993609 | SOLOGUARD LOCKING PLUS SYRINGE | MEG | Substantially Equivalent | Safeguard Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 24, 2001. 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.