FDA Registration
Active
🇲🇽 Mexico
LABORATORIOS LE ROY, S.A. DE C.V.
Reg #: 3000256895
·
FEI: 3000256895
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- LABORATORIOS LE ROY, S.A. DE C.V.
- Registration Number
- 3000256895
- FEI Number
- 3000256895
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CARRETERA YECAPLIXTLA -AGUA HEDIONDA KM. 2.5 S/N
- City
- YECAPIXTLA Morelos
- Country
- MX
Owner / Operator
- Firm Name
- LABORATORIOS LE ROY S.A. DE C.V.
- Operator Number
- 9048904
- Address
- AV. COYOACAN N 1622 TORRE UNO, PLANTA BAJA, COL. SANTA CRUZ ATOYAC, ALCALDIA BENITO JUAREZ
- City
- MEXICO CITY
- State
- MX-NOTA
- Postal Code
- 03310
- Country
- MX
- Correspondent
- HERNANDO - GARCIA
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177 ext. 412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2021-09-24 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2025-03-27 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2025-03-27 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2007-12-03 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2001-12-19 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2007-12-03 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2007-12-03 |
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Complaint File Establishment per 21 CFR 820.198