Contract manufacturerDeRoyal Industries, Inc. (New Tazewell, TN)TennesseeCardiovascularEar, nose and throatGastroenterology and urologyGeneral hospitalGeneral and plastic surgeryOphthalmicPhysical medicinePathologyClass IIClass I
DeRoyal Industries, Inc.
Contract manufacturer ยท New Tazewell, TN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1060680 (openFDA record; or search FDA's registration database)
- FEI number
- 1000208624
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Repackager or relabeler
- Owner or operator
- DEROYAL INDUSTRIES, INC. (FDA owner/operator no. 1044833)
- Registered address
- 1703 Highway 33 S, New Tazewell, TN 37825
- Contract listings
- 32 device listings, 30 product codes, first listed Feb 12, 1997
- 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 |
|---|---|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Sep 22, 2015 |
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract manufacturing | Dec 19, 2007 |
| EMX | Balloon, Epistaxis | Class I | Ear, nose and throat | Contract manufacturing | Jan 13, 2016 |
| FDE | Laparoscopy Kit | Class II | Gastroenterology and urology | Contract manufacturing | Mar 7, 2016 |
| FOD | Device, Occlusion, Umbilical | Class I | General hospital | Contract manufacturing | Feb 12, 1997 |
| FTA | Light, Surgical, Accessories | Class II | General and plastic surgery | Contract manufacturing | Sep 22, 2015 |
| FZZ | Marker, Skin | Class I | General and plastic surgery | Contract manufacturing | Aug 22, 2006 |
| GAX | Tourniquet, Nonpneumatic | Class I | General and plastic surgery | Contract manufacturing | Sep 28, 2005 |
| GCD | Connector, Catheter | Class I | General and plastic surgery | Contract manufacturing | Sep 25, 2012 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | Class I | General and plastic surgery | Contract manufacturing | Aug 22, 2006 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jan 19, 2017 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Mar 13, 2014 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class I | Ophthalmic | Contract manufacturing | Sep 25, 2012 |
| ILH | Splint, Hand, And Components | Class I | Physical medicine | Contract manufacturing | Jun 20, 2006 |
| ILO | Pack, Hot Or Cold, Water Circulating | Class II | Physical medicine | Contract manufacturing | Feb 28, 1997 |
| IQK | Orthosis, Cervical | Class I | Physical medicine | Contract manufacturing | Jun 20, 2006 |
| KDC | Instrument, Surgical, Disposable | Class I | General and plastic surgery | Contract manufacturing | Feb 21, 2001 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract manufacturing | Aug 3, 2001 |
| KDQ | Bottle, Collection, Vacuum | Class II | General hospital | Contract manufacturing | Oct 19, 2004 |
| KGY | Bag, Intestine | Class I | General and plastic surgery | Contract manufacturing | Nov 2, 2012 |
| LRP | Tray, Surgical | Class I | General and plastic surgery | Contract manufacturing | Feb 6, 2001 |
| LRS | I.V. Start Kit | Class II | General hospital | Contract manufacturing | Dec 10, 2015 |
| MCZ | Suture Removal Kit | Class I | General and plastic surgery | Contract manufacturing | Dec 10, 2015 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Aug 22, 2006 |
| MMP | Cover, Barrier, Protective | Class II | General and plastic surgery | Contract manufacturing | Sep 19, 2011 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | Class I | Pathology | Contract manufacturing | May 17, 2016 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | Class II | General and plastic surgery | Contract manufacturing | Oct 6, 2023 |
| OXQ | Dressing Change Tray | Class I | General hospital | Contract manufacturing | Dec 10, 2015 |
| PEZ | Central Venous Catheter Dressing Change Kit | Class II | General hospital | Contract manufacturing | Dec 10, 2015 |
| PUI | Drape, Surgical, Exempt | Class II | General and plastic surgery | Contract manufacturing | Aug 1, 2017 |