Contract manufacturerCustom Manufacturing Inc. (Elbert, CO)ColoradoCardiovascularGeneral and plastic surgeryClass IClass II
Custom Manufacturing Inc.
Contract manufacturer ยท Elbert, CO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1721251 (openFDA record; or search FDA's registration database)
- FEI number
- 1721251
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Custom Manufacturing, Inc. (FDA owner/operator no. 1721251)
- Registered address
- 12001 County Road 94, Elbert, CO 80106
- Contract listings
- 3 device listings, 3 product codes, first listed May 7, 1992
- 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 |
|---|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | May 7, 1992 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | May 22, 2024 |
| JOS | Electrode, Electrosurgical | Class II | General and plastic surgery | Contract manufacturing | May 22, 2024 |