Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007064560

FEI Number

3007064560

Entity Name

DISTRIBUIDORA INTERNACIONAL ARMAZONES MEXICO SA DE CV

City/State/Country

Col. Roma Ciudad de Mexico, MX

Establishment Address

Alvaro Obregon 121 Int. 303 Y 304, Col. Roma Ciudad de Mexico 06700, MX

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Distribuidora Internacional Armazones Mexico SA DE CV (Owner Number: 10050098)

Owner / Operator Contact Address

Alvaro Obregon 121 Int. 303 Y 304, Col. Roma Del. cuauhtemoc, CIUDAD DE MEXICO, MX-NOTA 06700, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182249

PMA Number

N/A

All Registered Proprietary Names

Acuvue 1 Day Moist Astigmatism Acuvue Oasys Astigmatism Acuvue Vita Ultra for Astigmatism

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2015-10-12
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2015-10-12
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-02-22
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2015-10-12
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2015-10-12
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2015-10-12
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-02-22
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-02-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-03-03
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-03-03
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-12-23
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2020-03-25
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2020-03-25

Official Correspondent

Hector Pastrana

US Agent Details

Harvey Berkowitz Business: Allied Vision Group Inc. Email: hb@avglens.com Phone: (561) 2121406

Related Public Records

Same Entity

Distribuidora Internacional Armazones Mexico SA DE CV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133079	Alden Optical Labs., Inc.	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)	2013-12-17
K941998	Ocu-Ease Optical Products, Inc.	OCU-FLEX-38 (POLYMACON)	1994-10-13
K992500	Cantor & Silver , Ltd.	CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS	1999-08-18
K984098	Adventures IN Color Technology, Ltd.	ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS	1999-05-10
K003161	Les Laboratoires Blanchard	ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT	2000-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses
Z-0044-2012	CooperVision Inc.	2	AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Z-0326-2026	Alcon Research LLC	2	Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Similar Registrations

Registration Number	Establishment Name	Location
3030261726	LENS PRO LTD	Salford, GB
1610287	Alcon Research, LLC	Fort Worth, TX, US
3006514242	CooperVision Manufacturing Ltd	Fareham Hampshire, GB
3035373204	1462287 BC UNLIMITED LIABILITY COMPANY	Surry British Columbia, CA
3010890435	ANGEL EYE CENTRE LTD.	Wembley Brent, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007064560. Last updated year: 2026. Please use registration number 3007064560 when referencing this establishment in official correspondence.