Certifications and Labels

ISO 13485

Facility: Exalta Athens | Legal Name: Turner Medical, Inc. | Location: Athens, AL USA | Expiration: 15 February 2027

Facility: Exalta Chatellerault | Legal Name: Coulot Decolletage, SAS | Location: Chatellerault, France | Expiration: 22 August 2025

Facility: Exalta Kenosha | Legal Name: Bradshaw Medical, Inc. | Location: Kenosha, WI USA | Expiration: 29 January 2028

Facility: Exalta Penang | Legal Name: Ortho Solutions, Sdn. Bhd. | Location: Penang, Malaysia | Expiration: 22 October 2026

Facility: Exalta Rang-du-Fliers | Legal Name: In'Tech Medical, SAS | Location: Rang-du-Fliers, France | Expiration: 17 July 2027

Facility: Exalta Rockaway | Legal Name: Intech Cases Inc. | Location: Rockaway, NJ USA | Expiration: 16 July 2027

Facility: Exalta Naples | Legal Name: Lenkbar, LLC | Location: Naples, FL USA | Expiration: 10 May 2027

Facility: Exalta Saint-Soupplets | Legal Name: Medical Conteneur, SAS | Location: Saint-Soupplets, France | Expiration: 16 July 2027

Facility: Exalta Toulon | Legal Name: In'Tech M2i, SAS | Location: Toulon, France | Expiration: 17 July 2027

FDA Registration

Facility: Exalta Athens | Legal Name: Turner Medical, Inc. | Location: Athens, AL USA

Facility: Exalta Chatellerault | Legal Name: Coulot Decolletage, SAS | Location: Chatellerault, France

Facility: Exalta Kenosha | Legal Name: Bradshaw Medical, Inc. | Location: Kenosha, WI USA

Facility: Exalta Naples | Legal Name: Lenkbar, LLC | Location: Naples, FL USA

Facility: Exalta Penang | Legal Name: Ortho Solutions, Sdn. Bhd. | Location: Penang, Malaysia

Facility: Exalta Rang-du-Fliers | Legal Name: In'Tech Medical, SAS | Location: Rang-du-Fliers, France

Facility: Exalta Rockaway | Legal Name: Intech Cases Inc. | Location: Rockaway, NJ USA

Facility: Exalta Saint-Soupplets | Legal Name: Medical Conteneur, SAS | Location: Saint-Soupplets, France

Japanese J-QMS

Facility: Exalta Kenosha | Legal Name: Bradshaw Medical, Inc. | Location: Kenosha, WI USA | Expiration: 19 August 2029

Facility: Exalta Penang | Legal Name: Ortho Solutions, Sdn. Bhd. | Location: Penang, Malaysia | Expiration: 15 February 2028

ANVISA (Brazil)

Facility: Exalta Chatellerault | Legal Name: Coulot Decolletage, SAS | Location: Chatellerault, France | Expiration: 15 September 2026

EU MDR

Facility: Exalta Kenosha | Legal Name: Bradshaw Medical, Inc. | Location: Kenosha, WI USA | Expiration: 15 September 2026

Resolve Credentials

MDSAP: Certificate 700908

ISO 13485: Certificate FM 703393

EU MDR: Certificate MDR 751413

MDD: Certificate CE 52820

UKCA: Certificate UKCA 778529