Data / Medical devices / Mexico / Distribuidora Internacional Armazones Mexico SA De CV
Distribuidora Internacional Armazones Mexico SA De CV: FDA-registered device maker in Col. Roma Ciudad de Mexico, Mexico, 8 510(k) clearances and 3 PMA approvals
Distribuidora Internacional Armazones Mexico SA De CV is registered with the FDA (registration 3007064560) in Col. Roma Ciudad de Mexico, Mexico. It lists 3 device types. The FDA files 8 510(k) clearances and 3 PMA approvals under its listings, the newest dated November 30, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007064560
- Address
- Alvaro Obregon 121 Int. 303 Y 304, Col. Roma Ciudad de Mexico, Mexico, 06700
- Owner or operator
- Distribuidora Internacional Armazones Mexico SA DE CV (10050098)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- October 12, 2015
- Registered through
- 2026
- Brand names listed
- Acuvue 1 Day Moist Astigmatism, Acuvue 2, Acuvue Oasys Astigmatism, Acuvue Vita, Bio True 1 Day, Ultra for Astigmatism, Ultra for Presbyopia
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Exporter to the US, Foreign private label distributor | 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 30, 2018 | K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| March 28, 2016 | K160212 | ACUVUE (senofilcon C) Soft Contact Lens | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| September 11, 2013 | K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | LPL | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| June 5, 2012 | K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| November 1, 2006 | K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| October 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| February 26, 2002 | K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | LPL | Substantially Equivalent | Vistakon | 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 |
| January 31, 1986 | P850079 | HYDRASOFT (METHAFILCON B) CONTACT LENS | LPM | 82 | September 1, 2020 | accessdata.fda.gov |
| April 24, 1984 | P830037 | DURASOFT(R) 3 FOR EXT WEAR | LPM | 50 | November 8, 2012 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lenses, Soft Contact, Extended Wear
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.