Contract manufacturerFABRITEQ (Knoxville, TN)TennesseeGastroenterology and urologyGeneral and plastic surgeryOphthalmicGeneral hospitalCardiovascularObstetrics and gynecologyClass IUnclassifiedClass II
FABRITEQ
Contract manufacturer · Knoxville, TN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010824458 (openFDA record; or search FDA's registration database)
- FEI number
- 3010824458
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- FabriTEQ (FDA owner/operator no. 10046621)
- Registered address
- 11220 Gilbert Dr, Knoxville, TN 37932
- Contract listings
- 12 device listings, 11 product codes, first listed Apr 16, 2014
- 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 |
|---|---|---|---|---|---|
| EYJ | Holder, Ureteral Catheter | Class I | Gastroenterology and urology | Contract manufacturing | Apr 16, 2014 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract manufacturing | Feb 11, 2015 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class I | Ophthalmic | Contract manufacturing | Feb 25, 2016 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract manufacturing | Sep 10, 2025 |
| KGX | Tape And Bandage, Adhesive | Class I | General hospital | Contract manufacturing | Jan 11, 2017 |
| KMK | Device, Intravascular Catheter Securement | Class I | General hospital | Contract manufacturing | Feb 25, 2016 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Dec 19, 2019 |
| NAC | Dressing, Wound, Hydrophilic | Class I | General and plastic surgery | Contract manufacturing | Apr 24, 2015 |
| NAD | Dressing, Wound, Occlusive | Class I | General and plastic surgery | Contract manufacturing | Apr 16, 2014 |
| PNU | Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery | Class II | Obstetrics and gynecology | Contract manufacturing | May 22, 2023 |
| PUK | Administration Set Securement Device | Class I | General hospital | Contract manufacturing | Jun 26, 2017 |