Data / Medical devices / Mexico / DKT DE MEXICO S.A. de C.V.
DKT DE MEXICO S.A. de C.V.: FDA-registered device maker in Ciudad de Mexico, Mexico, 4 510(k) clearances
DKT DE MEXICO S.A. de C.V. is registered with the FDA (registration 3012909279) in Ciudad de Mexico, Mexico. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 12, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012909279
- Address
- Avenida Anillo de Circunvalacion 127 Tercer Piso Colonia Atlantida, Ciudad de Mexico, Mexico, 04370
- Owner or operator
- DKT de Mexico S.A. de C.V. (10055943)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- October 19, 2017
- Registered through
- 2026
- Brand names listed
- Condom, PRUDENCE CLASSIC, PRUDENCE SENSITIVE, Prudence Banana, Prudence Chocolate, Prudence Mint, Prudence Strawberry, Ultra Thin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Exporter to the US, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 12, 2015 | K150743 | Water Based Personal Lubricant with Flavours | NUC | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| September 24, 2004 | K041837 | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| December 19, 2000 | K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
Compare with other makers
Updated November 12, 2015. 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.