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Data / Medical devices / Mexico / Wear Tex S. De R.L. De C.V.

Wear Tex S. De R.L. De C.V.: FDA-registered device maker in Torreon Coahuila, Mexico, 3 510(k) clearances

Wear Tex S. De R.L. De C.V. is registered with the FDA (registration 3013410562) in Torreon Coahuila, Mexico. It lists 24 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 2, 2010. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Wear Tex S. De R.L. De C.V.
FDA registration number
3013410562
Address
312 Hilatura, Torreon Coahuila, Mexico, 27272
Owner or operator
Wear Tex S. de R.L. de C.V. (10052848)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
October 12, 2016
Registered through
2027
Brand names listed
Alba Sterile Stockinette, Albahealth Guardian compression sleeve, Albahealth Impervious Stockinette, Anti-Embolism Stocking (C.A.R.E. brands), C.A.R.E Span, Care-Nett, Cotton Stockinette, Encompass Group, LLC and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Bandage, CastITG1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Component, CastLGF1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Drape, Adhesive, AerosolKGT1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Gown, ExaminationFME1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier ProtectionQPC2Contract manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the US, Manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Protector, Skin PressureFMP1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Sheet, BurnFPY1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Contract manufacturer, Exporter to the USaccessdata.fda.gov
System, Thermal RegulatingDWJ2Exporter to the US, Manufactureraccessdata.fda.gov
Table, Operating-Room, PneumaticFWW1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Wrap, SterilizationFRG2Exporter to the US, Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 2, 2010K101705MISTRAL-AIR WARMING SYSTEMDWJSubstantially EquivalentThe Surgical Company International B.V.accessdata.fda.gov
January 20, 2000K992436GOWN BACK, MODEL 13-403N; 13-404N; 13-405NFYASubstantially EquivalentTechstylesaccessdata.fda.gov
October 28, 1992K921243CONVERTORS STERILIZATION WRAPFRGSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov

Compare with other makers

Updated July 2, 2010. 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.