Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005899764

FEI Number

3005899764

Entity Name

STERIS MEXICO, S. de R.L. de C.V.

City/State/Country

GUADALUPE Nuevo Leon, MX

Establishment Address

AVENIDA AVANTE 790,, PARQUE INDUSTRIAL GUADALUPE, GUADALUPE Nuevo Leon 67190, MX

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

STERIS Corporation (Owner Number: 10078069)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203061

PMA Number

N/A

All Registered Proprietary Names

AMSCO 400 Series Medium Steam Sterilizer Models 39SL, 39CSL (MY-MF) V-PRO 60 Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) V-PRO S2 Low Temperature Sterilization System (MY-MF, CM-SD) Loading Car 26x26x61-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x49-inch (MY-MF) Loading Car 26x26x49-inch (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x61-inch (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x49-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x61-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-800, HC-1000 (MY-MF) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) AMSCO C Series Steam Sterilizer Models 16C, 16CS, 20C, 20CS (MY-REM) AMSCO Series 400 Steam Sterilizer Models 16, 16S, 20, 20S (MY-MF) AMSCO 400 Series Medium Steam Sterilizer Models 39SL, 39CSL (MY-MF) AMSCO 400 Medium Steam Sterilizer 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL, 60CSL (MY-MF) AMSCO Evolution Floorloading Steam Sterilizer Models HC-3000 (MY-MF) AMSCO Evolution Floorloading Steam Sterilizer Models HC-2000 (MY-MF) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) AMSCO 600 Steam Sterilizer (MY-MF) Extra Shelf for Loading Car (MY-CFE) AMSCO 600 Extra Shelf for Rack and 2 Shelves (AX000B7) (MY-MF) AMSCO 600 Rack and 2 Shelves (AX000B6) (MY-MF) Loading Car with 2 Shelves (MY-CFE) ALUS Load/Unload Table for AMSCO 600 Steam Sterilizer (MY-CFE) Loading Car Side and End Rails (MY-CFE) AMSCO Century Small Steam Sterilizer Models V-116, V-120 VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) Amsco V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO Evolution Medium Steam Sterilizer Models HC-900 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-1200 (MY-MF) V-PRO S2 Low Temperature Sterilization System (MY-MF, CM-SD) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) V-PRO 60 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) Amsco V-PRO 1 Low Temperature Sterilization Systems (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) Eagle Rack & Three Shelves 16x16x26-inch (MY-MF) ATLAS Loading Car 24x36x60-inch (MY-MF) Eagle Bottom Shelf & Support 16x16x26-inch (MY-MF) Eagle Rack & Three Shelves 20x20x38-inch (MY-MF) Eagle Shelf for 37 3/8-inch Chambers (MY-MF) Eagle Rack & Two Shelves 20x20x38-inch (MY-MF) ATLAS Loading Car and Transfer Carriage 24x36x48-inch (MY-MF) Rack & Two Shelves 24x36x48-inch for Single Door (MY-MF) Rack & Two Shelves 24x36x36-inch (MY-MF) ATLAS Transfer Carriage 24x36x48-inch (MY-MF) ATLAS Loading Car 24x36x48-inch (MY-MF) Eagle Loading Cart 24 1/4x57 5/8x37 3/8-inch (MY-MF) Eagle Rack & Two Shelves 16x16x26-inch (MY-MF) Amsco Eagle 3000 Series Remanufactured Steam Sterilizer (MY-CFE) Eagle Loading Cart 24 1/4x38x37 3/8-inch (MY-MF) ATLAS Loading Car 24x36x36-inch (MY-MF) ATLAS Transfer Carriage 24x36x36-inch (MY-MF) Eagle Bottom Shelf & Support 20x20x38-inch (MY-MF) Rack & Two Shelves 24x36x48-inch for Double Door (MY-MF) ATLAS Transfer Carriage 24x36x60-inch (MY-MF) AMSCO 600 STEAM Sterilizer (MY-MF) Loading Car with 2 Shelves (MY-CFE) AMSCO 600 Extra Shelf for Rack and 2 Shelves (AX000B7) (MY-MF) AMSCO 600 Rack and 2 Shelves (AX000B6) (MY-MF) ALUS Load/Unload Table for AMSCO 600 Steam Sterilizer (MY-CFE) Extra Shelf for Loading Car (MY-CFE) Loading Car Side and End Rails (MY-CFE) V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) AMSCO Eagle 3017 EO sterilizer (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) V-PRO 60 Low Temperature Sterilization System (MY-CFE) AMSCO Evolution Medium Steam Sterilizer Models HC-1500 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-600 (MY-MF) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE) V-PRO 60 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) V-PRO maX 2 Low Temperature Sterilization System (MY-MF) AMSCO 600 STEAM Sterilizer (MY-MF) ALUS Load/Unload Table for AMSCO 600 Steam Sterilizer (MY-CFE) RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (QB-MF) V-PRO s2 Low Temperature Sterilization System (MY-MF) RAS 12 Long Rack (FD257) (QB-MF) RAS 12 Rack (FD256) (QB-MF) V-PRO 60 Low Temperature Sterilization System (MY-CFE) AMSCO 600 Extra Shelf for Rack and 2 Shelves (AX000B7) (MY-MF) Loading Car Side and End Rails (MY-CFE) Loading Car with 2 Shelves (MY-CFE) AMSCO 600 Rack and 2 Shelves (AX000B6) (MY-MF) AMSCO 600 STEAM Sterilizer (MY-MF) Extra Shelf for Loading Car (MY-CFE) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) ATLAS Transfer Carriage 26x37.5x36" Hinged Door (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-900, HC-1200 (MY-MF) ATLAS Loading Car 26x37.5x48" (MY-MF) ATLAS Loading Car 26x37.5x36" (MY-MF) Shelf, Full Width/Length 26x37.5x36" (MY-MF) ATLAS Transfer Carriage 26x37.5x48" Hinged Door (MY-MF) Rack & Two 36" Shelves 26x37.5x36 for Evolution Amsco 400 Century (MY-MF) ATLAS Transfer Carriage 26x37.5x48" Horizontal Sliding Door (MY-MF) ATLAS Transfer Carriage 26x37.5x36" for Horizontal Sliding Door (MY-MF) V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) VAPROX HC Sterilant (PB011 and PB012) (MM-MF, CM-SD) AMSCO Evolution Floorloading Steam Sterilizer Models HC-2000 (MY-MF) Amsco Eagle 3000 Series Vacamatic Floorloader (MY-CFE) AMSCO Evolution Floorloading Steam Sterilizer Models HC-3000 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-1000 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-800 (MY-MF) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) V-PRO 60 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) ATLAS Transfer Carriage 26x37.5x36-inch for Horizontal Sliding Door (MY-MF) Shelf, Full Width/Length 26x37.5x36-inch (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x49-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x49-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-1500 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-1000 (MY-MF) ATLAS Loading Car 26x37.5x48-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x61-inch (MY-MF) ATLAS Loading Car 26x37.5x36-inch (MY-MF) ATLAS Transfer Carriage 26x37.5x48-inch Horizontal Sliding Door (MY-MF) Loading Car 26x26x39-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-900 (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x61-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-600 (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x39-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x39-inch (MY-MF) ATLAS Loading Car 26x37.5x60-inch (MY-MF) ATLAS Transfer Carriage 26x37.5x48-inch Hinged Door (MY-MF) Loading Car 26x26x49-inch (MY-MF) Evolution ALUS Load/Unload Table (MY-CFE) ATLAS Transfer Carriage 26x37.5x60-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-1200 (MY-MF) Loading Car 26x26x61-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-800 (MY-MF) ATLAS Transfer Carriage 26x37.5x36-inch Hinged Door (MY-MF)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2021-11-08
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
PEC	Sterilizer Automated Loading System	General Hospital	Class 2	880.6880	2021-09-03
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2021-09-03
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2023-10-22
PEC	Sterilizer Automated Loading System	General Hospital	Class 2	880.6880	2023-10-22
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2023-09-18
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	Class 2	880.6860	2020-10-09
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
PEC	Sterilizer Automated Loading System	General Hospital	Class 2	880.6880	2022-10-15
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2022-10-15
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2022-10-15
NVE	Washer, Cleaner, Automated, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2022-10-15
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-10-13
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2020-10-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2020-11-17
PEC	Sterilizer Automated Loading System	General Hospital	Class 2	880.6880	2020-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS Corporation Email: becky_aldhizer@steris.com Phone: (440) 3927490

Related Public Records

Same Entity

STERIS Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21
K142034	3M Company	3M STERI-VAC STERILIZER/AERATOR	2015-01-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2014	Advanced Sterilization Products	2	STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0044-2014	Advanced Sterilization Products	2	STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0022-2013	3M Company Health Care Business 3M Center	2	3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.

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3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL
3027434168	Tuttnauer Kft.	Dunakeszi Pest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005899764. Last updated year: 2026. Please use registration number 3005899764 when referencing this establishment in official correspondence.