FDA Registration
Active
🇬🇹 Guatemala
Fiber, Medical, Absorbent - DeRoyal
Reg #: 3010452421
·
FEI: 3010452421
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Ortho and Surgical Products Enterprises S.A.
- Registration Number
- 3010452421
- FEI Number
- 3010452421
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KM 20.5 Carretera a Villa Canales, Zona 3 Finca Morancito,
- City
- Villa Canales Guatemala
- Country
- GT
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
US Agent
- Business Name
- DeRoyal Industries, Inc.
- Contact Name
- Elizabeth Reed
- Address
- 200 Debusk Ln
- City
- Powell
- State
- TN
- ZIP
- 37849
- Country
- US
- [email protected]
- Phone
- 865 3621256
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2006-08-22 |
Proprietary Names
Fiber, Medical, Absorbent - DeRoyal
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device