FDA Registration
Active
🇲🇽 Mexico
AMSCO Series 400 Steam Sterilizer Models 16, 16S, 20, 20S (MY-MF)
Reg #: 3005899764
·
FEI: 3005899764
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STERIS MEXICO, S. de R.L. de C.V.
- Registration Number
- 3005899764
- FEI Number
- 3005899764
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- AVENIDA AVANTE 790,, PARQUE INDUSTRIAL GUADALUPE
- City
- GUADALUPE Nuevo Leon
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K212424
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS Corporation
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2021-11-08 |
Proprietary Names
AMSCO Series 400 Steam Sterilizer Models 16, 16S, 20, 20S (MY-MF)
AMSCO 400 Series Medium Steam Sterilizer Models 39SL, 39CSL (MY-MF)
AMSCO C Series Steam Sterilizer Models 16C, 16CS, 20C, 20CS (MY-REM)
AMSCO 400 Medium Steam Sterilizer 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL, 60CSL (MY-MF)
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device