Data / Medical devices / Bulgaria / Smart Soft Healthcare
Smart Soft Healthcare: FDA-registered device maker in Varna, Bulgaria, 2 510(k) clearances
Smart Soft Healthcare is registered with the FDA (registration 3029900829) in Varna, Bulgaria. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029900829
- Address
- 113 Gen. Kolev Str., suite 7.2, Varna, Bulgaria, 9002
- Owner or operator
- Smart Soft Healthcare (10088940)
- Roles
- Manufacturer
- First device listed
- July 16, 2025
- Registered through
- 2026
- Brand names listed
- CoLumbo, CoLumboX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 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 |
|---|---|---|---|---|---|---|
| May 28, 2025 | K250367 | CoLumboX | QIH | Substantially Equivalent | Smart Soft Healthcare AD | accessdata.fda.gov |
| August 15, 2024 | K241211 | CoLumbo | QIH | Substantially Equivalent | Smart Soft Healthcare | accessdata.fda.gov |
Compare with other makers
Updated May 28, 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.