Contract manufacturerDeRoyal Industries, Inc. (Powell, TN)TennesseeGeneral hospitalGeneral and plastic surgeryObstetrics and gynecologyOphthalmicPhysical medicinePathologyCardiovascularClass IClass II
DeRoyal Industries, Inc.
Contract manufacturer ยท Powell, TN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1057404 (openFDA record; or search FDA's registration database)
- FEI number
- 1000208576
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- DEROYAL INDUSTRIES, INC. (FDA owner/operator no. 1044833)
- Registered address
- 300 DEBUSK LN., Powell, TN 37849
- Contract listings
- 16 device listings, 16 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 |
|---|---|---|---|---|---|
| FNY | Basin, Emesis | Class I | General hospital | Contract manufacturing | May 16, 2001 |
| FOD | Device, Occlusion, Umbilical | Class I | General hospital | Contract manufacturing | Feb 12, 1997 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | May 16, 2001 |
| FTA | Light, Surgical, Accessories | Class II | General and plastic surgery | Contract manufacturing | Sep 22, 2015 |
| HGE | Amniotome | Class I | Obstetrics and gynecology | Contract manufacturing | Aug 3, 2001 |
| HOE | Caliper, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Sep 25, 2012 |
| IQI | Orthosis, Limb Brace | Class I | Physical medicine | Contract manufacturing | Jun 20, 2006 |
| KDC | Instrument, Surgical, Disposable | Class I | General and plastic surgery | Contract manufacturing | Feb 21, 2001 |
| KDQ | Bottle, Collection, Vacuum | Class II | General hospital | Contract manufacturing | Oct 19, 2004 |
| KYW | Container, Liquid Medication, Graduated | Class I | General hospital | Contract manufacturing | Aug 22, 2006 |
| KYX | Dispenser, Liquid Medication | Class I | General hospital | Contract manufacturing | Aug 25, 2005 |
| LRP | Tray, Surgical | Class I | General and plastic surgery | Contract manufacturing | Feb 6, 2001 |
| LYU | Accessory, Surgical Apparel | Class I | General and plastic surgery | Contract manufacturing | Aug 25, 2005 |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | Class I | Obstetrics and gynecology | Contract manufacturing | Aug 21, 2009 |
| NNI | Container, Specimen, Non-Sterile | Class I | Pathology | Contract manufacturing | Aug 22, 2006 |
| OFA | Cardiovascular Surgical Instruments Tray | Class I | Cardiovascular | Contract manufacturing | May 24, 2021 |