Data / Medical devices / Romania / Hobian S.R.L.
Hobian S.R.L.: FDA-registered device maker in Bucharest Bucuresti, Romania, 4 510(k) clearances
Hobian S.R.L. is registered with the FDA (registration 3045753434) in Bucharest Bucuresti, Romania. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045753434
- Address
- Drumul Gura Calitei, Nr. 17B, Ground floor, Apt. 4, District 3, Bucharest Bucuresti, Romania, 032604
- Owner or operator
- HOBIAN S.R.L. (10095991)
- Roles
- Exporter to the US
- First device listed
- June 4, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | accessdata.fda.gov |
| Transcranial Magnetic Stimulator | OBP | 2 | 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 |
|---|---|---|---|---|---|---|
| August 17, 2024 | K240234 | BTL-899MS | IPF | Substantially Equivalent | BTL Industries, Inc. | accessdata.fda.gov |
| March 28, 2024 | K233604 | BTL-785S | GEI | Substantially Equivalent | BTL Industries, Inc. | accessdata.fda.gov |
| March 4, 2022 | K212723 | BTL-995-rTMS | OBP | Substantially Equivalent | BTL Industries, Inc. | accessdata.fda.gov |
| November 14, 2018 | K181497 | HPM-6000UF | KPI | Substantially Equivalent | BTL Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Transcranial Magnetic Stimulator
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
Updated August 17, 2024. 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.