Skip to content
menu-toggle
menu-close
English

Certifications

All Intech facilities are certified and registered with the FDA 

 

Facility

Legal Name

City/country

ISO 13485

intechAthens

Turner Medical, Inc.

Athens, AL/USA

⬇️Download now

intechChatellerault

Coulot Decolletage, SAS

Chatellerault,France

⬇️Download now

intechKenosha

Bradshaw Medical, Inc.

Kenosha, WI/USA

⬇️Download now

intechPenang

Ortho Solutions, Sdn. Bhd.

Penang, Malaysia

⬇️Download now

intechRang-Du-Fliers

In’Tech Medical, SAS

Rang-Du-Fliers, France

⬇️Download now

intechRockaway

Intech Cases Inc.

Rockaway,NJ/USA

⬇️Download now

intechNaples

Lenkbar, LLC

Naples,FL/ USA

⬇️Download now

intechSaint-Soupplets

Medical Conteneur, SAS

Saint-Soupplets, France

⬇️Download now

intechToulon

In'Tech M2i, SAS

Toulon, France

⬇️Download now

Facility

Legal Name

City/country

FDA Registration #

intechAthens

Turner Medical, Inc.

Athens,AL

USA

3005706667

intechChatellerault

Coulot Decolletage SAS

Chatellerault

France

3006217744

intechKenosha

Bradshaw Medical, Inc.

Kenosha,WI

USA

3006846753

intechNaples

Lenkbar LLC

Naples, FL

USA

3011307621

intechPenang

Ortho Solutions, Sdn. Bhd.

Penang

Malaysia

3012755988

intechRang-Du-Fliers

In’Tech Medical SAS

Rang-Du-Fliers

France

9611579

intechRockaway

Intech Cases Inc.

Rockaway,NJ

USA

025301715

intechSaint-Soupplets

Medical Conteneur, SAS 

Saint-Soupplets

France

3006846753

Facility

Legal Name

City/country

Japanese J-QMS

intechKenosha

Bradshaw Medical, Inc.

Kenosha, WI/USA

⬇️Download now

intechPenang

Ortho Solutions, Sdn. Bhd.

Penang, Malaysia

⬇️Download now for site 1 

⬇️Download now for site 2

ANVISA Certification refers to the process of obtaining certification from the Brazilian Health Regulatory Agency, known as ANVISA (Agência Nacional de Vigilância Sanitária). ANVISA is responsible for regulating and overseeing various products related to health, sanitation, and consumer safety in Brazil.

 

Facility

Legal Name

City/Country

ANVISA

intechChatellerault

Coulot Decolletage SA

Chatellerault, France

⬇️Download now

 

Facility

Legal Name

City/country

EU MDR Certificate

intechKenosha

Bradshaw Medical, Inc.

Kenosha, WI/USA

⬇️Download now