FDA Registration
Active
🇺🇸 United States
VMCore Biopsy Needle
Reg #: 3027269340
·
FEI: 3027269340
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- URO1 MEDICAL, INC.
- Registration Number
- 3027269340
- FEI Number
- 3027269340
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3703 Alliance Drive, Suite A
- City
- Greensboro
- State
- NC
- ZIP
- 27407
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201650
Owner / Operator
- Firm Name
- Uro1 Medical, Inc.
- Operator Number
- 10087857
- Address
- 3703 Alliance Drive, Suite A
- City
- Greensboro
- State
- NC
- Postal Code
- 27407
- Country
- US
- Correspondent
- Thomas Lawson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2023-04-20 |
Proprietary Names
VMCore Biopsy Needle
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device