FDA Registration
Active
🇺🇸 United States
DEROYAL INDUSTRIES, INC.
Reg #: 1034876
·
FEI: 1034876
·
Expires 2026
Products
25
Proprietary Names
28
Establishment Types
2
Classifications
25
Registration Details
- Registration Name
- DEROYAL INDUSTRIES, INC.
- Registration Number
- 1034876
- FEI Number
- 1034876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 185 RICHARDSON WAY
- City
- MAYNARDVILLE
- State
- TN
- ZIP
- 37807
- Country
- US
Owner / Operator
- Firm Name
- DEROYAL INDUSTRIES, INC.
- Operator Number
- 1044833
- Address
- 200 DEBUSK LN., --
- City
- Powell
- State
- TN
- Postal Code
- 37849
- Country
- US
- Correspondent
- Elizabeth Reed
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2005-04-14 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2001-08-03 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2004-12-09 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2010-08-23 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2015-09-15 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2006-06-20 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2007-12-28 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2005-08-08 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2005-08-08 |
| Pad, Neonatal Eye | FOK | Class 1 | General Hospital | No | 2001-08-03 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2020-08-11 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2018-11-01 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2004-12-09 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2012-09-25 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2004-06-23 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2006-07-27 |
| Catheter, Continuous Irrigation | GBQ | Class 1 | General, Plastic Surgery | No | 2015-11-09 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2005-08-25 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2003-04-04 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2001-02-21 |
| Incubator, Neonatal | FMZ | Class 2 | General Hospital | No | 2012-04-25 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 1999-05-21 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2014-02-10 |
Proprietary Names
Bedding Disposable, Medical - DeRoyal
Kit, Surgical Instrument, Disposable - DeRoyal
Sheet, Burn - DeRoyal
Dressing, Wound, Drug - DeRoyal
Multidex
Restraint, Protective - DeRoyal
Splint, Hand, and Components - DeRoyal
WRIST
Dressing, Wound, Drug - DeRoyal / Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic - DeRoyal
Silver Alginate Cath Patch Dressing - DeRoyal
Joint, Ankle, External Brace - DeRoyal
Support, Patient Position - DeRoyal
Pad, Neonatal Eye - DeRoyal
Warmer, Infant Radiant - DeRoyal
Device, Transfer, Patient, Manual - DeRoyal
Dressing, Wound, Occlusive - DeRoyal
Tape, Measuring, Rulers and Calipers - DeRoyal
Instrument, Manual, Surgical, General Use - DeRoyal
Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal
Dressing, Wound, Hydrophilic - DeRoyal
Protector, Skin Pressure - DeRoyal
Catheter, Continuous Irrigation - DeRoyal
Accessory, Surgical Apparel - DeRoyal
Tape and Bandage, Adhesive - DeRoyal
Instrument, Surgical, Disposable - DeRoyal
Incubator, Neonatal - Warmer, Infant Radiant - DeRoyal
Cushion, Wheelchair - DeRoyal
Monitor, Bed Patient - DeRoyal
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device