FDA Registration
Active
🇷🇸 Serbia
VISARIS D.O.O.
Reg #: 3012569470
·
FEI: 3012569470
·
Expires 2026
Products
5
Proprietary Names
24
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- VISARIS D.O.O.
- Registration Number
- 3012569470
- FEI Number
- 3012569470
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Batajnicki drum 10. deo 1B
- City
- Zemun Beograd
- Country
- RS
Regulatory Submissions
- 510(k) Number
- K150725
Owner / Operator
- Firm Name
- Visaris d.o.o.
- Operator Number
- 10051372
- Address
- Batajnicki drum 10. deo 1B
- City
- Zemun
- State
- Beograd
- Postal Code
- 11080
- Country
- RS
US Agent
- Business Name
- Kamm & Associates
- Contact Name
- Daniel Kamm
- Address
- 8870 Ravello Ct
- City
- Naples
- State
- FL
- ZIP
- 34114
- Country
- US
- [email protected]
- Phone
- 847 3741727
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube Mount, X-Ray, Diagnostic | IYB | Class 1 | Radiology | No | 2016-03-08 |
| Table, Radiographic, Non-Tilting, Powered | IZZ | Class 2 | Radiology | No | 2016-03-08 |
| Table, Radiographic, Stationary Top | IXQ | Class 2 | Radiology | No | 2019-11-24 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2016-03-08 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2016-03-08 |
Proprietary Names
Vision V Rad Floor Stand TFS
Vision C Rad Vertical Stand BVS
Vision C Rad Ceiling Stand TCS
Vision C Rad Table BTE
MPT 600
Vision Mobile Patient Table
Avanse
Avanse DR
LuminX DR Retrofit
ddRAura DRive Kit
Vision C
Vision V
Vision U
Vision X
LuminX Overhead
LuminX Overhead Auto
LuminX U-Arm Auto
LuminX Straight Arm
LuminX FMTS
ddRAura S
ddRAura OTC
ddRAura OTC APS
ddRAura U
ddRAura FMTS
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device