FDA Registration
Active
🇦🇹 Austria
PIUR tUS Infinity
Reg #: 3020928588
·
FEI: 3020928588
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PIUR IMAGING GMBH
- Registration Number
- 3020928588
- FEI Number
- 3020928588
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hamburgerstrasse 11/7
- City
- Vienna Wien
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K240036
Owner / Operator
- Firm Name
- PIUR IMAGING GmbH
- Operator Number
- 10091767
- Address
- Kaiserstrasse 8/1/11
- City
- Vienna
- State
- Wien
- Postal Code
- 1070
- Country
- AT
- Correspondent
- Frederik Bender
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 Nw 12th St Ste 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 305 5999373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-10-31 |
Proprietary Names
PIUR tUS Infinity
Establishment Types
Manufacture Medical Device