Data / Medical devices / Mexico / Parcex Estrategia Y Negocio SA De CV
Parcex Estrategia Y Negocio SA De CV: FDA-registered device maker in SAN PEDRO GARZA GARCIA Nuevo Leon, Mexico, 1 510(k) clearance and 1 PMA approval
Parcex Estrategia Y Negocio SA De CV is registered with the FDA (registration 3014289638) in SAN PEDRO GARZA GARCIA Nuevo Leon, Mexico. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated December 6, 2005. 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
- 3014289638
- Address
- Ricardo Margain Zozaya 565 Int301 Fracc Parque Corporativo Sta Engracia, SAN PEDRO GARZA GARCIA Nuevo Leon, Mexico, 66267
- Owner or operator
- PARCEX ESTRATEGIA Y NEGOCIO SA DE CV (10057076)
- Roles
- Exporter to the US
- First device listed
- February 23, 2018
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | 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 |
|---|---|---|---|---|---|---|
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 11, 2001 | P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | LPM | 83 | May 29, 2026 | accessdata.fda.gov |
Compare with other makers
Updated May 29, 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.