Contract manufacturerMaterialise USA, LLC. (Plymouth, MI)MichiganPhysical medicineOrthopedicClass IClass II
Materialise USA, LLC.
Contract manufacturer · Plymouth, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3005718816 (openFDA record; or search FDA's registration database)
- FEI number
- 3005718816
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- MATERIALISE N.V. (FDA owner/operator no. 9029485)
- Registered address
- 44650 Helm Court, Plymouth, MI 48170
- Contract listings
- 3 device listings, 5 product codes, first listed Jun 13, 2017
- 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 |
|---|---|---|---|---|---|
| KNP | Orthosis, Corrective Shoe | Class I | Physical medicine | Contract manufacturing | Jan 22, 2019 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Jun 13, 2017 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jun 13, 2017 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Jun 13, 2017 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Class II | Orthopedic | Contract manufacturing | Sep 19, 2018 |