MedtechSourcebook

ACCUMEDIX, INC.

Contract manufacturer ยท Libertyville, IL

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2008Product codes first listed, by year (tallest: 4)2026
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 codeDevice (FDA name)ClassCategoryRoleFirst listed
DXFCatheter, SeptostomyClass IICardiovascularContract manufacturingJun 20, 2024
DZEImplant, Endosseous, Root-FormClass IIDentalContract manufacturingApr 21, 2008
DZNInstruments, Dental HandClass IDentalContract manufacturingNov 12, 2008
EBLPin, Retentive And Splinting, And Accessory InstrumentsClass IDentalContract manufacturingFeb 9, 2021
EHYTray, Impression, PreformedClass IDentalContract manufacturingDec 26, 2009
EJLBur, DentalClass IDentalContract manufacturingDec 26, 2009
EPNPump, Nebulizer, ManualClass IEar, nose and throatContract manufacturingNov 7, 2018
FZSCurette, Surgical, General UseClass IGeneral and plastic surgeryContract manufacturingAug 21, 2025
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredClass IIGeneral hospitalContract manufacturingNov 7, 2018
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredClass IGeneral and plastic surgeryContract manufacturingJul 24, 2020
GEXPowered Laser Surgical InstrumentClass IIGeneral and plastic surgeryContract manufacturingDec 5, 2022
HGXPump, Breast, PoweredClass IIObstetrics and gynecologyContract manufacturingMar 30, 2022
HGYPump, Breast, Non-PoweredClass IObstetrics and gynecologyContract manufacturingMar 31, 2022
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingMar 25, 2024
NDPAccessories, Implant, Dental, EndosseousClass IDentalContract manufacturingNov 12, 2008
NHAAbutment, Implant, Dental, EndosseousClass IIDentalContract manufacturingDec 26, 2009
OATImplant, Endosseous, OrthodonticClass IIDentalContract manufacturingJun 29, 2022
PUDLabware, Assisted Reproduction, ExemptClass IIObstetrics and gynecologyContract manufacturingSep 11, 2023
QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric ConditionsClass IINeurologyContract manufacturingJan 29, 2021
SBNDigital Therapy Device For Convergence InsufficiencyClass IOphthalmicContract manufacturingDec 12, 2024