FDA Registration
Active
🇩🇰 Denmark
AGITO MEDICAL
Reg #: 3007562060
·
FEI: 3007562060
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- AGITO MEDICAL
- Registration Number
- 3007562060
- FEI Number
- 3007562060
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bejlerholm 3a
- City
- Norresundby Nordjylland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K221190
Owner / Operator
- Firm Name
- AGITO Medical A/S
- Operator Number
- 10091434
- Address
- Bejlerholm 3B
- City
- Norresundby
- State
- Nordjylland
- Postal Code
- 9400
- Country
- DK
- Correspondent
- Christian Frandsen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-05-07 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-05-07 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2025-05-07 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-05-07 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device