FDA Registration
Active
🇺🇸 United States
BREAST-MED INC.
Reg #: 3009192245
·
FEI: 3009192245
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BREAST-MED INC.
- Registration Number
- 3009192245
- FEI Number
- 3009192245
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10580 Wayzata Blvd Ste 150
- City
- Hopkins
- State
- MN
- ZIP
- 55305
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133697
Owner / Operator
- Firm Name
- Breast-Med Inc.
- Operator Number
- 10093970
- Address
- 10580 Wayzata Blvd. Suite 150
- City
- Hopkins
- State
- MN
- Postal Code
- 55305
- Country
- US
- Correspondent
- Michael T Nelson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2025-08-26 |
Proprietary Names
Breast-Med Tissue Marker
VizMark Preloaded Tissue Marker
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility