Contract manufacturerACCUMEDIX, INC. (Libertyville, IL)IllinoisCardiovascularDentalEar, nose and throatGeneral and plastic surgeryGeneral hospitalObstetrics and gynecologyOrthopedicNeurologyOphthalmicClass IIClass I
ACCUMEDIX, INC.
Contract manufacturer ยท Libertyville, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1424785 (openFDA record; or search FDA's registration database)
- FEI number
- 3003473212
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- ACCUMEDIX, INC. (FDA owner/operator no. 9046081)
- Registered address
- 800 Liberty Drive, Libertyville, IL 60048
- Contract listings
- 32 device listings, 20 product codes, first listed Apr 21, 2008
- 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 |
|---|---|---|---|---|---|
| DXF | Catheter, Septostomy | Class II | Cardiovascular | Contract manufacturing | Jun 20, 2024 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | Contract manufacturing | Apr 21, 2008 |
| DZN | Instruments, Dental Hand | Class I | Dental | Contract manufacturing | Nov 12, 2008 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Class I | Dental | Contract manufacturing | Feb 9, 2021 |
| EHY | Tray, Impression, Preformed | Class I | Dental | Contract manufacturing | Dec 26, 2009 |
| EJL | Bur, Dental | Class I | Dental | Contract manufacturing | Dec 26, 2009 |
| EPN | Pump, Nebulizer, Manual | Class I | Ear, nose and throat | Contract manufacturing | Nov 7, 2018 |
| FZS | Curette, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Aug 21, 2025 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class II | General hospital | Contract manufacturing | Nov 7, 2018 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class I | General and plastic surgery | Contract manufacturing | Jul 24, 2020 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract manufacturing | Dec 5, 2022 |
| HGX | Pump, Breast, Powered | Class II | Obstetrics and gynecology | Contract manufacturing | Mar 30, 2022 |
| HGY | Pump, Breast, Non-Powered | Class I | Obstetrics and gynecology | Contract manufacturing | Mar 31, 2022 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Mar 25, 2024 |
| NDP | Accessories, Implant, Dental, Endosseous | Class I | Dental | Contract manufacturing | Nov 12, 2008 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | Contract manufacturing | Dec 26, 2009 |
| OAT | Implant, Endosseous, Orthodontic | Class II | Dental | Contract manufacturing | Jun 29, 2022 |
| PUD | Labware, Assisted Reproduction, Exempt | Class II | Obstetrics and gynecology | Contract manufacturing | Sep 11, 2023 |
| QMZ | Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions | Class II | Neurology | Contract manufacturing | Jan 29, 2021 |
| SBN | Digital Therapy Device For Convergence Insufficiency | Class I | Ophthalmic | Contract manufacturing | Dec 12, 2024 |