Contract manufacturerCOMDEL INNOVATION, LLC (Wahpeton, ND)North DakotaDentalPhysical medicineGeneral hospitalNeurologyClass IClass II
COMDEL INNOVATION, LLC
Contract manufacturer ยท Wahpeton, ND
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3007361893 (openFDA record; or search FDA's registration database)
- FEI number
- 3007361893
- Registered for
- FDA registration year 2027
- Establishment types
- Contract manufacturer
- Owner or operator
- ComDel Innovation, LLC (FDA owner/operator no. 10042112)
- Registered address
- 2100 15th St N, Wahpeton, ND 58075
- Contract listings
- 5 device listings, 5 product codes, first listed Oct 22, 2012
- 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 |
|---|---|---|---|---|---|
| ELZ | Crown, Preformed | Class I | Dental | Contract manufacturing | Oct 30, 2019 |
| ISA | Massager, Therapeutic, Electric | Class I | Physical medicine | Contract manufacturing | Mar 13, 2018 |
| LJL | Detectors And Removers, Lice, (Including Combs) | Class I | General hospital | Contract manufacturing | Oct 22, 2012 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Aug 11, 2020 |
| QLV | Field Generator Positioning Device | Class I | Neurology | Contract manufacturing | Dec 22, 2021 |