Contract manufacturerSUMMIT MEDICAL LLC (Saint Paul, MN)MinnesotaAnesthesiologyEar, nose and throatOphthalmicGeneral and plastic surgeryClass IIClass IUnclassified
SUMMIT MEDICAL LLC
Contract manufacturer · Saint Paul, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3008719017 (openFDA record; or search FDA's registration database)
- FEI number
- 3008719017
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Summit Medical, LLC (FDA owner/operator no. 10033920)
- Registered address
- 815 Vikings Pkwy Ste 100, Saint Paul, MN 55121
- Contract listings
- 11 device listings, 10 product codes, first listed Oct 19, 2010
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Class II | Anesthesiology | Contract manufacturing | Oct 19, 2010 |
| EPP | Splint, Nasal | Class I | Ear, nose and throat | Contract manufacturing | Oct 19, 2010 |
| ETD | Tube, Tympanostomy | Class II | Ear, nose and throat | Contract manufacturing | Oct 19, 2010 |
| HMX | Cannula, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Jun 24, 2024 |
| HNN | Knife, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Jun 24, 2024 |
| HOZ | Sponge, Ophthalmic | Class II | Ophthalmic | Contract manufacturing | Jul 14, 2021 |
| KCN | Ear Wick | Class I | Ear, nose and throat | Contract manufacturing | Oct 19, 2010 |
| KDC | Instrument, Surgical, Disposable | Class I | General and plastic surgery | Contract manufacturing | Oct 19, 2010 |
| LYA | Splint, Intranasal Septal | Class I | Ear, nose and throat | Contract manufacturing | Oct 19, 2010 |
| MJV | Device, Inflation, Middle Ear | Unclassified | Ear, nose and throat | Contract manufacturing | Oct 19, 2010 |