Skip to the page

Data / Medical devices / Dominican Republic / Proex Corp, S.R.L.

Proex Corp, S.R.L.: FDA-registered device maker in Ens La Julia Santo Domingo, Dominican Republic, 2 510(k) clearances

Proex Corp, S.R.L. is registered with the FDA (registration 3014213264) in Ens La Julia Santo Domingo, Dominican Republic. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 23, 2007. Registered through 2026. FDA data exported November 2, 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.

FDA registration number
3014213264
Address
Primera No. 4, Edificio Mariposa VI Apartamento No.2, Ens La Julia Santo Domingo, Dominican Republic, 0000
Owner or operator
Proex Corp, S.R.L. (10056630)
Roles
Exporter to the US
First device listed
September 26, 2018
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Hood, SurgicalFXY2Exporter to the USaccessdata.fda.gov
Sterilant, Medical DevicesMED2Exporter to the USaccessdata.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
March 23, 2007K063005STRYKER T6 HOODS AND TOGASFYASubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
August 17, 2000K993042MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANTMEDSubstantially EquivalentMedivators, Inc.accessdata.fda.gov

Compare with other makers

Updated March 23, 2007. 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.