Scholten Surgical Instruments has over 30 years of Medical Manufacturing Experience.
Scholten Surgical Instruments introduces the all new Novatome single-use disposable Endomyocardial biopsy forceps.
Scholten Surgical Instruments is alwaysTrusted for its uncompromising quality and reliability.
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Regulatory Compliance

Manufacture/Device Registrations

  • FDA Medical Device Establishment Registration, Registration Number: 2936330

  • State of California Department of Public Health, Food and Drug Branch, Device Manufacturing License number: 45088

  • Australian TGA (Therapeutic Goods Administration) Device Registration

  • Health Canada Device Registration

  • Ministry of Health of Italy

  • The Ministry of Health, Welfare and Sport, Netherlands



ENTE CERTIFICAZIONE MACCHENE (ECM) - Notified Body

Scholten Surgical's Quality Management System is verified by ENTE CERTIFICAZIONE MACCHINE srl (ECM) to meet the following Quality Management System Standards:

EN ISO13485:2016 Certificate

Medical Devices Directive 93/42/EEC Conformity Certificate



Lloyd's Register Quality Assurance

Scholten Surgical's Quality Management System is verified by Lloyd's Register Quality Assurance to meet the (MDSAP) Medical Device Single Audit Program requirements:



Global Regulatory Representative

    Emergo Australia, Sydney, Australia
    Telephone: +61.2.9006.1662
  • Emergo Europe, The Hague, Netherlands
    Telephone: +31.70.345.8570A

 

 

     

 

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