FDA Registration
Active
🇩🇰 Denmark
Adora DRFi
Reg #: 1000188474
·
FEI: 1000188474
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NRT X-RAY A/S
- Registration Number
- 1000188474
- FEI Number
- 1000188474
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BIRKEGAARDSVEJ 16
- City
- HASSELAGER Midtjylland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K242948
Owner / Operator
- Firm Name
- NRT X-RAY A/S
- Operator Number
- 9059076
- Address
- BIRKEGAARDSVEJ 16, --
- City
- HASSELAGER
- State
- DK-NOTA
- Postal Code
- 8361
- Country
- DK
US Agent
- Business Name
- REGULATORY INSIGHT, INC.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-02-17 |
Proprietary Names
Adora DRFi
Establishment Types
Manufacture Medical Device