FDA Registration
Active
🇨🇷 Costa Rica
DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
Reg #: 9613793
·
FEI: 3006469671
·
Expires 2026
Products
18
Proprietary Names
24
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
- Registration Number
- 9613793
- FEI Number
- 3006469671
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GLOBAL PARK, 602 PARKWAY
- City
- LA AURORA, HEREDIA
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K954088
Owner / Operator
- Firm Name
- DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
- Operator Number
- 9032613
- Address
- GLOBAL PARK, P.O. BOX 180-3006, 602 PARKWAY
- City
- LA AURORA, HEREDIA
- State
- CR-NOTA
- Postal Code
- 146
- Country
- CR
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 |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2016-11-28 |
| Catheter, Upper Urinary Tract | EYC | Class 2 | Gastroenterology, Urology | No | 2005-09-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-01-26 |
| Stethoscope, Esophageal, With Electrical Conductors | BZT | Class 2 | Anesthesiology | No | 2020-04-28 |
| Incubator, Neonatal | FMZ | Class 2 | General Hospital | No | 2005-09-14 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2005-09-14 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2005-09-14 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2013-06-05 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-02-10 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2010-09-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2010-09-20 |
| Electrocautery, Gynecologic (And Accessories) | HGI | Class 2 | Obstetrics/Gynecology | No | 2016-01-28 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2015-12-30 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2005-09-14 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2005-09-14 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2015-10-12 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2022-09-13 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2025-09-10 |
Proprietary Names
Thermometer, Electronic, Clinical - DeRoyal
VARIOUS FOLEY CATHETERS
Catheter, Upper Urinary Tract - DeRoyal
Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal
Stethoscope, Esophageal, with Electrical Conductors - DeRoyal
Incubator, Neonatal - Warmer, Infant Radiant - DeRoyal
Gauze/Sponge, nonresorbable for external use - DeRoyal
Electrosurgical, cutting & coagulation & Accessories - DeRoyal
Device, Occlusion, Umbilical - DeRoyal
Warmer, Infant Radiant - DeRoyal
Arthroscope - DeRoyal
Cutter, Surgical - DeRoyal
Instrument, Manual, Surgical, General Use - DeRoyal
Arthroscope - Electrosurgical, Cutting & Coagulation & Accessories DeRoyal
Electrocautery, Gynecologic (and Accessories)- DeRoyal
Laparoscope, General & Plastic Surgery - DeRoyal
VARIOUS ELECTROSURGICAL
Pack, Hot or Cold, Water Circulating - DeRoyal
COLD THERAPY PRODU
Scissors, Medical, Disposable - DeRoyal
Dissector, Surgical, General & Plastic Surgery - DeRoyal
GENERAL PURPOSE PROBES
Applicator, Absorbent Tipped, Sterile - DeRoyal
Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device