FDA Registration
Active
🇺🇸 United States
ACCUMEDIX, INC.
Reg #: 1424785
·
FEI: 3003473212
·
Expires 2026
Products
20
Proprietary Names
32
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- ACCUMEDIX, INC.
- Registration Number
- 1424785
- FEI Number
- 3003473212
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 800 Liberty Drive
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- Country
- US
Owner / Operator
- Firm Name
- ACCUMEDIX, INC.
- Operator Number
- 9046081
- Address
- 800 Liberty Drive, --
- City
- Libertyville
- State
- IL
- Postal Code
- 60048
- Country
- US
- Correspondent
- Michele H Kupcso
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2008-04-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-03-25 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2009-12-26 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-02-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2008-11-12 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2018-11-07 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-12-05 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2009-12-26 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2018-11-07 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2022-03-30 |
| Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions | QMZ | Class 2 | Neurology | No | 2021-01-29 |
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2023-09-11 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2025-08-21 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2022-03-31 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2021-02-09 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2020-07-24 |
| Catheter, Septostomy | DXF | Class 2 | Cardiovascular | No | 2024-06-20 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2022-06-29 |
| Pump, Nebulizer, Manual | EPN | Class 1 | Ear, Nose, Throat | No | 2018-11-07 |
| Digital Therapy Device For Convergence Insufficiency | SBN | Class 1 | Ophthalmic | No | 2024-12-12 |
Proprietary Names
Blue Sky Bio Dental Implant
TrapEz
SurePass CTR
Blue Sky Bio Dental Bur
Zygomatic Implant System
Double Hex Implant System
Blue Sky Bio Implant Accessories
Pinkband Dental Band
Flycast Technologies Dental Band
Novilase Laser Therapy System and Novilase Breast ILT Packs
Blue Sky Bio Pterygoid Implants and Abutments
Blue Sky Bio Impression Copings
Osteomedix Bone Particle Collector
Bio Conus, Bio Max, and Bio Quattro Implant Systems
Breast Shells 36mm (12 pack)
Steril Kit D26 - 10 Pack
Sterile Kit D26
Calypso To Go Pure TX
NightWare
NovoSort; ProteX; ProteX Safe-Seal
SURGICAL CURETTE
Amaryll Essentials (10 pack)
Dental Implant Accessory Instruments
Blue Sky Bio CAD-CAM Abutments
HOTWIRE RF Guidewire
One Stage Implant System
Atraverse Hotwire Radiofrequency Guidewires
Calypso Pro Complete TX
Blue Sky Bio TAD
ARDO Alyssa Handsfree Plus Kit
Tian Tx360 Nasal Applicator
VERVE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)