FDA Registration
Active
🇺🇸 United States
MEDSPIRA LLC
Reg #: 3008414621
·
FEI: 3008414621
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MEDSPIRA LLC
- Registration Number
- 3008414621
- FEI Number
- 3008414621
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2718 Summer St NE
- City
- Minneapolis
- State
- MN
- ZIP
- 55413
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031119
Owner / Operator
- Firm Name
- MEDSPIRA LLC
- Operator Number
- 10030584
- Address
- 2718 Summer Street N.E.
- City
- Minneapolis
- State
- MN
- Postal Code
- 55413
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2009-10-20 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2009-10-20 |
| Monitor, Esophageal Motility, Anorectal Motility, And Tube | KLA | Class 2 | Gastroenterology, Urology | No | 2012-09-12 |
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2025-12-19 |
Proprietary Names
Medspira BC-10 1.5T
Integrated Breath Hold Control Sys.
Breath Hold
mcompass Anorectal Manometry System
Medspira BC-10 3T
mcompass Biofeedback Anorectal Manometry System.
mcompass Anorectal Balloon Expulsion Catheter
Establishment Types
Manufacture Medical Device