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
Phone
440 3927490

Products

Device Name Product Code
Sterilizer, Steam FLE

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