Contract manufacturerOSYPKA MEDTEC INC. (Longmont, CO)ColoradoEar, nose and throatAnesthesiologyClass IIClass III
OSYPKA MEDTEC INC.
Contract manufacturer ยท Longmont, CO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010376846 (openFDA record; or search FDA's registration database)
- FEI number
- 3010376846
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Repackager or relabeler
- Owner or operator
- Osypka Medtec Inc. (FDA owner/operator no. 10044669)
- Registered address
- 1804 Skyway Dr Unit E, Longmont, CO 80504
- Contract listings
- 3 device listings, 2 product codes, first listed Jul 11, 2013
- 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 |
|---|---|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | Class II | Ear, nose and throat | Contract manufacturing | Jul 11, 2013 |
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | Class III | Anesthesiology | Contract manufacturing | Sep 12, 2024 |