Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011134834

FEI Number

3011134834

Entity Name

TECMA OPERACIONES S. DE R.L. DE C.V.

City/State/Country

Juarez Chihuahua, MX

Establishment Address

Blvd. Zaragoza NO. 650, Colonia La Perla, Juarez Chihuahua 32590, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tecma Operaciones S. de R.L. de C.V. (Owner Number: 10047328)

Owner / Operator Contact Address

Santos Dumont 6620, Parque Industrial Panamericano, Juarez, MX-CHH 32695, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

bioskin BIOSKIN BIOSKIN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-02-19
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2016-03-28
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2016-02-19

Official Correspondent

Cristian Colin

US Agent Details

Flor Quinonez Business: Salcedo Customs International Inc Email: imports@salcedobrokers.com Phone: (915) 8810400

Related Public Records

Same Entity

Tecma Operaciones S. de R.L. de C.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011106828	TECMA OPERACIONES S. DE R.L. DE C.V.	Juarez Chihuahua, MX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011134834. Last updated year: 2026. Please use registration number 3011134834 when referencing this establishment in official correspondence.