Data / Medical devices / Hungary / Sempermed KFT.
Sempermed KFT.: FDA-registered device maker in SOPRON Gyor-Moson-Sopron, Hungary, 4 510(k) clearances
Sempermed KFT. is registered with the FDA (registration 9614502) in SOPRON Gyor-Moson-Sopron, Hungary. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 19, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9614502
- FEI number
- 3003189428
- Address
- 14 Somfalvy U., SOPRON Gyor-Moson-Sopron, Hungary, 9400
- Owner or operator
- Harps Europe Manufacturing (8020005)
- Roles
- Repackager or relabeler
- First device listed
- December 6, 2007
- Registered through
- 2027
- Brand names listed
- Dealmed, Henry Schein Criterion PI, Latex Surgical, Pivetal, Sempermed Derma Powder Free Surgeon Gloves, Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves, Sempermed Syntegra UV, Syntegra Green and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| August 19, 2025 | K250313 | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | KGO | Substantially Equivalent | Harps Europe Manufacturing GmbH | accessdata.fda.gov |
| March 31, 2020 | K191860 | Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential | KGO | Substantially Equivalent | Semperit Technische Produkte Gesellchaft M.B.H. | accessdata.fda.gov |
| May 2, 2017 | K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | KGO | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| January 16, 2002 | K013560 | SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 | KGO | Substantially Equivalent | Semperit Technische Produkte Gesellshaft | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2025. 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.