Data / Medical devices / Mexico / STERIS MEXICO, S. de R.L. de C.V.
STERIS MEXICO, S. de R.L. de C.V.: FDA-registered device maker in GUADALUPE Nuevo Leon, Mexico, 42 510(k) clearances
STERIS MEXICO, S. de R.L. de C.V. is registered with the FDA (registration 3005899764) in GUADALUPE Nuevo Leon, Mexico. It lists 5 device types. The FDA files 42 510(k) clearances under its listings, the newest dated June 24, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005899764
- Address
- Avenida Avante 790, Parque Industrial Guadalupe, GUADALUPE Nuevo Leon, Mexico, 67190
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer
- First device listed
- October 9, 2020
- Registered through
- 2027
- Brand names listed
- ALUS Load/Unload Table for AMSCO 600 Steam Sterilizer (MY-CFE), ALUS Load/Unload Table for AMSCO 700 Steam Sterilizer (MY-CFE), AMSCO 400 Medium Steam Sterilizer 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL, 60CSL (MY-MF), AMSCO 400 Medium Steam Sterilizer 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL, 60CSL (MY-MF), AMSCO 400 Series 20-inch Intermediate Shelf (MY-MF), AMSCO 400 Series Medium Steam Sterilizer Models 39SL, 39CSL (MY-MF), AMSCO 600 Extra Shelf for Rack and 2 Shelves (AX000B7) (MY-MF), AMSCO 600 Rack and 2 Shelves (AX000B6) (MY-MF) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer Automated Loading System | PEC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sterilizer, Chemical | MLR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sterilizer, Ethylene-Oxide Gas | FLF | 2 | Complaint file establishment | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Washer, Cleaner, Automated, Endoscope | NVE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 24, 2026 | K261055 | AMSCO 700 Steam Sterilizer | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 20, 2023 | K233065 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | Steris | accessdata.fda.gov |
| September 13, 2023 | K232485 | AMSCO 600 Steam Sterilizer | FLE | Substantially Equivalent | Steris | accessdata.fda.gov |
| August 7, 2023 | K223476 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 30, 2022 | K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | NVE | Substantially Equivalent | Steris | accessdata.fda.gov |
| September 9, 2022 | K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | MLR | Substantially Equivalent | Steris | accessdata.fda.gov |
| August 25, 2022 | K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | NVE | Substantially Equivalent | Steris | accessdata.fda.gov |
| October 28, 2021 | K212424 | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 25, 2021 | K211500 | AMSCO 600 Medium Steam Sterilizer | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| November 6, 2020 | K203061 | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 9, 2019 | K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 5, 2019 | K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 27, 2019 | K183410 | AMSCO 600 Steam Sterilizer | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 3, 2019 | K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 9, 2018 | K173481 | Amsco Evolution Medium Steam Sterilizer | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 23, 2018 | K173493 | Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 22, 2018 | K173490 | Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 22, 2018 | K173485 | Amsco Evolution Medium Steam Sterilizer | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172754 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 18, 2018 | K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 31, 2017 | K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 6, 2016 | K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 24, 2014 | K140498 | V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 16, 2013 | K131120 | AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 26, 2012 | K120632 | AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 8, 2012 | K112403 | AMSCO CHIMERON MEDIUM STEAM STERLILZER | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 16, 2011 | K112055 | AMSCO CHIMERON MEDIUM STEAM STERILIZER | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 1, 2011 | K112813 | AMSCO V-PRO | MLR | Substantially Equivalent | Steris Corp | accessdata.fda.gov |
| November 22, 2011 | K112760 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 20, 2011 | K111223 | AMSCO CHIMERON SMALL STEAM STERILIZER | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 2, 2011 | K111810 | AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 18, 2011 | K102394 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 12, 2011 | K102330 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| November 4, 2009 | K092490 | AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 17, 2009 | K091731 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 3, 2009 | K083097 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 29, 2009 | K091136 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 30, 2008 | K082435 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 4, 2007 | K062297 | VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 26, 2003 | K030789 | AMSCO CENTURY STEAM STERILIZER | FLE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 1, 1998 | K964332 | EAGLE CENTURY STEAM STERILIZER | FLE | Substantially Equivalent | Amsco Intl., Inc. | accessdata.fda.gov |
| February 7, 1994 | K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | FLF | Substantially Equivalent | American Sterilizer Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilizer, Chemical
- All makers of Sterilizer, Steam
- All makers of Sterilizer Automated Loading System
- All makers of Washer, Cleaner, Automated, Endoscope
- All makers of Sterilizer, Ethylene-Oxide Gas
Updated June 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.