Data / Medical devices / Mexico / Enlaces Corporativos 55 Del Norte S.A. De C.V.
Enlaces Corporativos 55 Del Norte S.A. De C.V.: FDA-registered device maker in MEXICO Ciudad de Mexico, Mexico, 2 510(k) clearances and 6 PMA approvals
Enlaces Corporativos 55 Del Norte S.A. De C.V. is registered with the FDA (registration 3030421258) in MEXICO Ciudad de Mexico, Mexico. It lists 5 device types. The FDA files 2 510(k) clearances and 6 PMA approvals under its listings, the newest dated October 20, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030421258
- Address
- Paseo De San Francisco 105 Col Jardines De Atizapan Municipio Atizapan De Zaragoza, MEXICO Ciudad de Mexico, Mexico, 52978
- Owner or operator
- ENLACES CORPORATIVOS 55 DEL NORTE S.A. DE C.V. (10089687)
- Roles
- Exporter to the US
- First device listed
- December 28, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | QIT | 3 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| October 20, 2020 | K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| November 15, 2019 | P180035 | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear | QIT | 34 | February 17, 2026 | accessdata.fda.gov |
| April 30, 2018 | P170035 | Bausch + Lomb Ultra (samfilcon A) Contact Lenses | LPM | 18 | September 14, 2026 | accessdata.fda.gov |
| December 20, 2005 | P040045 | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPM | 143 | October 16, 2026 | accessdata.fda.gov |
| October 11, 2001 | P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | LPM | 83 | May 29, 2026 | accessdata.fda.gov |
| April 24, 1984 | P830037 | DURASOFT(R) 3 FOR EXT WEAR | LPM | 50 | November 8, 2012 | accessdata.fda.gov |
| March 18, 1980 | N18033 | ACUVUE CONTACT LENS | LPM | 107 | April 17, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Lenses, Soft Contact, Extended Wear
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
- All makers of Dressing, Wound, Occlusive
Updated February 17, 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.