FDA Registration
Active
🇩🇰 Denmark
BioXmark
Reg #: 3010629041
·
FEI: 3010629041
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Nanovi A/S
- Registration Number
- 3010629041
- FEI Number
- 3010629041
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Diplomvej 378
- City
- Kgs. Lyngby Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- DEN220017
Owner / Operator
- Firm Name
- Medtec LLC
- Operator Number
- 9033077
- Address
- 1401 8TH ST., S.E., --
- City
- Orange City
- State
- IA
- Postal Code
- 51041
- Country
- US
- Correspondent
- Alena - Newgren
US Agent
- Business Name
- MEDTEC LLC
- Contact Name
- Alena Newgren
- Address
- 1401 8th St Se
- City
- Orange City
- State
- IA
- ZIP
- 51041
- Country
- US
- [email protected]
- Phone
- 319 2486650
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Phase-Changing Fiducial Marker For Radiation Therapy | QUV | Class 2 | Radiology | No | 2023-11-15 |
Proprietary Names
BioXmark
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility