Contract manufacturerTPI Custom Solutions (Ham Lake, MN)MinnesotaGeneral hospitalDentalClass IClass II
TPI Custom Solutions
Contract manufacturer ยท Ham Lake, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3023194188 (openFDA record; or search FDA's registration database)
- FEI number
- 3023194188
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- TPI Custom Solutions (FDA owner/operator no. 10085509)
- Registered address
- 13828 Lincoln St. NE, Ham Lake, MN 55304
- Contract listings
- 3 device listings, 3 product codes, first listed Jun 27, 2022
- 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 |
|---|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | Class I | General hospital | Contract manufacturing | Jun 27, 2022 |
| LGM | Chamber, Patient Isolation | Class II | General hospital | Contract manufacturing | May 16, 2025 |
| MYB | Pillow, Cervical (For Mild Sleep Apnea) | Class II | Dental | Contract manufacturing | May 16, 2025 |