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.
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- 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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gown, Surgical | FYA | 2 | Exporter to the US | accessdata.fda.gov |
| Hood, Surgical | FXY | 2 | Exporter to the US | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| March 23, 2007 | K063005 | STRYKER T6 HOODS AND TOGAS | FYA | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| August 17, 2000 | K993042 | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT | MED | Substantially Equivalent | Medivators, 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.