FDA Registration
Active
🇺🇸 United States
NuCart
Reg #: 3009028104
·
FEI: 3009028104
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ONDAL MEDICAL SYSTEMS OF AMERICA, INC.
- Registration Number
- 3009028104
- FEI Number
- 3009028104
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 540 Eastpark Ct Ste A
- City
- Sandston
- State
- VA
- ZIP
- 23150
- Country
- US
Owner / Operator
- Firm Name
- Ondal Medical Systems of America, Inc.
- Operator Number
- 10042526
- Address
- 540 Eastpark Court, Suite A
- City
- Sandston
- State
- VA
- Postal Code
- 23150
- Country
- US
- Correspondent
- Terry T Ward
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2024-11-01 |
Proprietary Names
NuCart
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198