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Certifications

All Intech facilities are certified and registered with the FDA 

 

Facility

Legal Name

City

Country

Expiration Date

ISO 13485

intechAthens

Turner Medical, Inc.

Athens, AL

USA

15 February 2027

⬇️Download now

intechChatellerault

Coulot Decolletage, SAS

Chatellerault

France

22 August 2025

⬇️Download now

intechKenosha

Bradshaw Medical, Inc.

Kenosha, WI

USA

29 January 2025

⬇️Download now

intechPenang

Ortho Solutions, Sdn. Bhd.

Penang

Malaysia

22 October 2026

⬇️Download now

intechRang-Du-Fliers

In’Tech Medical, SAS

Rang-Du-Fliers

France

17 July 2027

⬇️Download now

intechRockaway

Intech Cases Inc.

Rockaway, NJ

USA

16 July 2027

⬇️Download now

intechNaples

Lenkbar, LLC

Naples, FL

USA

10 May 2027

⬇️Download now

intechSaint-Soupplets

Medical Conteneur, SAS

Saint-Soupplets

France

16 July 2027

⬇️Download now

intechToulon

In'Tech M2i, SAS

Toulon

France

17 July 2027

⬇️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

Expiration Date

Japanese J-QMS

intechKenosha

Bradshaw Medical, Inc.

Kenosha, WI

USA

19 August 2029

⬇️Download now

intechPenang

Ortho Solutions, Sdn. Bhd.

Penang,

Malaysia

15 February 2028

⬇️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

Expiration Date

ANVISA

intechChatellerault

Coulot Decolletage SAS

Chatellerault

France

15 September 2026

⬇️Download now

 

Facility

Legal Name

City

Country

Expiration Date

EU MDR Certificate

intechKenosha

Bradshaw Medical, Inc.

Kenosha, WI

USA

15 September 2026

⬇️Download now