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Sign in to claim this brandMEDSPIRA LLC
US
Last updated September 17, 2026
What MEDSPIRA LLC makes
Medspira LLC manufactures gastrointestinal motility analysis systems, including anorectal manometry devices and associated software for diagnostic assessment. Their portfolio also includes breath-hold systems—comprising patient belts, remote displays, and base stations—to aid in MRI imaging by reducing motion artifacts. Additional products include rectosphincteric balloons for medical testing and radio-frequency coils for MRI systems. Accessories like syringes, cables, and commodes are also part of their offerings.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Medspira LLC operates from the United States, adhering to applicable U.S. medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 2718 Summer St NE, Minneapolis, MN, 55413
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3008414621
- DUNS Number
- —
Catalogue (54)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Assy, Philips 23' Pulmo Chest Bellows, Tubing ES | 459800663242 | FDA UDI | Class II | Active |
| mcompass Biofeedback Anorectal Manometry System | K143031 | FDA 510(k) | Class II | Active |
| Mcompass Anorectal Manometry System | K120088 | FDA 510(k) | Class II | Active |
| mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | K252605 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Medspira LLC has one FDA recall record initiated on June 14, 2017, which is recorded as terminated. The recall was due to a potential failure in the balloon bond of the inner catheter stem, which could result in the balloon separating from the inner stem and remaining in the rectal cavity.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 14, 2017 | Z-3072-2017 | — | terminated | Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity. |