Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009131011

FEI Number

3009131011

Entity Name

MEDTECH ACUNA S.A. DE C.V.

City/State/Country

Acuna Coahuila, MX

Establishment Address

Juarez No. 200 Altos, B, Acuna Coahuila 26200, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MedTech Acuna S.A. de C.V. (Owner Number: 10036114)

Owner / Operator Contact Address

Juarez 200, Letra B Altos, Acuna, MX-COA 26200, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wrist Support Elbow Support Foam Cervical Collar Knee Support

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2011-04-20
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2011-04-20
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2023-12-11
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2011-04-20
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2011-04-20
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2011-04-20
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2011-04-20
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2011-04-20
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2011-04-20
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2011-04-20
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2011-04-20
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2011-04-20

Official Correspondent

No official correspondent registered.

US Agent Details

Sam Shaffer Business: L&R USA INC. Email: sam.shaffer@us.LRmed.com Phone: (414) 8924157

Related Public Records

Same Entity

MedTech Acuna S.A. de C.V.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009131011. Last updated year: 2026. Please use registration number 3009131011 when referencing this establishment in official correspondence.