BREG MEXICO, S. DE R.L. DE C.V. (3)

FDA Device Registration & Listing · Mexicali Baja California, MX · Registration 3015960622

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015960622
FEI Number
3015960622
Entity Name
BREG MEXICO, S. DE R.L. DE C.V. (3)
City/State/Country
Mexicali Baja California, MX
Establishment Address
AVENIDA CIRCULO DE LA AMISTAD #2701, PARQUE INDUSTRIAL PIMSA IV, Mexicali Baja California 21229, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Breg Inc (Owner Number: 10041297)
Owner / Operator Contact Address
2382 Faraday Avenue, Suite 300, Carlsbad, CA 92008, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Deluxe Shoulder Sling Arc 2 Essential Shoulder Immob. Essential Shoulder Sling Shoulder Immob. Deluxe Slingshot 3 Shoulder Abduction Pillow Slingshot Neutral Wedge Atlas Shoulder Brace Curtis Shoulder Sleeve Kool Sling Sling and Swathe Universal Curtis Shoulder Cuff Slingshot 2 Straight Shoulder Immobilizer Accessories - Waistband Strap, Shoulder Stabilizer, Sling Pediatric Accessories - Extension Strap, Closure Extension, Shoulder Strap, Hand Attachment, Shoulder Pad, Abduction Pillow Pro-Fitt TLSO Actimove Loc 462 Ascend TLSO 456/457 Pinnacle TLSO 464 Epic LP TLSO 456 Accessories - Conversion Pad, Extension Panel KNOCKOUT WRIST NEUTRAL HAND ATTACHMENT CX2K ESSENTIAL ELBOW IMMOB THIGH SUPPORT STACK FINGER SPLINT TENNIS ELBOW STRAP ADJ DONUT CALF SLEEVE ADJ NIGHT SPLINT PHX HAND EXT TENDON COMPRESSION STRAP UNIVERSAL HORESHOE HINGED KNEE BRACE SOFTGAIT ALIGNER PHX WRIST LACER KNEE SUPPORT ELBOW TSCOPE BUTTRESS SUPPORT LAT STABILIZER X2K ELBOW M-BRACE PATELLA STABILIZER T-CHECK LACE UP ANKLE ARC DYNAMIC System Loc Actimove Fit 627 Actimove Fit 631 Actimove Fit 637 V-Loc Cinch Loc Lumbar Loc Pro-Fitt LSO Core Loc Deluxe Pinnacle 627/631/637/639 Ascend SI Ascend 627/631/637 Epic LP LO627/LSO631/LSO637 Lumbar Support Back Support BOA Back Brace Accessories - Extension Panel, Pad Kit, Upgrade Kit, Back Pad Essential Spine 627/642, 631/648, 637/650 Pinnacle Belt/LSO Ascend LSO Tri-Panel Knee Immob Original Knee OR Merit Z-13 Axiom Wee-Rom Z-12 20.50 Patellofemoral DUO Jet Thruster RLF Revolution 3 G3 Extender Plus Quantum OA T-Scope Premier Post-Op LPR Latitude OA Knee Genesis Undersleeve Patella Guard Hi-Performance Hinged Knee FreeRunner Lateral Stabilizer EPO Recover X2K Knee Brace OA Impulse Economy Hinged Knee Slide Guard ShortRunner PTO Crossover Hinge Cover RoadRunner Freestyle FreeSport Solus Knee Brace Fusion Knee Accessories - Condyle and Hook, Patella Buttress, Strap set, Strap Tab, Strap Pad, Calf Strap, Condyle, Hex Key MC Knee Brace Knee Support Accessories - Stop Kit, Soft Toe Guard, Soft Goods, Shoe Insert, Buckle, Chafe Tab, Shoe insert, Hard toe guard Accessories - Incision Pad, Pad, Pad Kit, Refurb Kit, Cuff, Wrap Set, Hinge Kit, Shims Kit CrossRunner Performance Knit Hinged Measuring System, Fit Kit Freestyle Plus TopShelf Fusion Strap Set Single Panel Knee Immob Elbow/Knee Sleeve Brace Cover Undersleeve Suspension Sleeve Clavicle Support IntelliFlo Pads Wrap on Polar Pads Glacier, Glacier Combo Kodiak, Kodiak Combo Cube, Cube Combo Accessories - Y-Adapter, Transformer, Strap, Battery Pack, Bed Hanger, Extension Tube FastForm SCB VERSI Strip FastForm SCB Universal Gutter Multifunctional Orthosis FastForm Wrist Cast FastForm SCB Hook & Loop refresh Strips FastForm SCB Short Arm Multifunctional Orthosis FastForm SCB Thumb Spica Multifunctional Orthosis Elasto-Fit Wrist Support Vinyl Splint Thumb Support Wrist Guard Universal Wrist Splint Universal Wrist Brace Classic Wrist Brace Versafit Wrist Brace Versafit Thumb Contender Brace Wrist Stabilizer Cock-Up Thumb Guard Wrist Cock Up Splint Thumbster Low Profile Wrist Premier Thumb Splint Wrist Mate Wrist Lacer Wrist Pro Apollo Wrist Brace Wrist Complete FastForm SCB Immobilizer FastForm SCB Hand-based thumb Spica Orthosis FastForm SCB Tension Straps Universal Thumb Lacer FastForm SCB VERSI Sheet Abdominal Binder Surgical Binder Ankle Therapy Kit Knee Therapy Kit Shoulder Therapy Kit Ortholux Ace Centron Lumbolux Ninja Vertalux Extender

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ILI Sling, Arm Physical Medicine Class 1 890.3640 2012-08-17
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2013-07-16
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2012-07-10
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2012-08-17
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2012-07-27
IPM Cover, Limb Physical Medicine Class 1 890.3025 2012-08-17
IQJ Splint, Clavicle Physical Medicine Class 1 890.3490 2017-02-01
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2012-07-27
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2012-08-17
KTD Orthosis, Abdominal Physical Medicine Class 1 890.3490 2017-02-01
IOD Components, Exercise Physical Medicine Class 1 890.5350 2012-08-17
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2015-05-17

Official Correspondent

Monique Zamora

US Agent Details

Monique Zamora Business: BREG INC Email: mzamora@breg.com Phone: (760) 2710004

Related Public Records

Same Entity

Breg Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010694026 BREG, INC. Indianapolis, IN, US
2028253 BREG, INC., Carlsbad, CA, US
3027500264 BREG MEXICO, S. DE R.L. DE C.V. (4) Mexicali Baja California, MX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015960622. Last updated year: 2026. Please use registration number 3015960622 when referencing this establishment in official correspondence.
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