directory BFC Industries

CISTEO MEDICAL

Last update : 17/10/2023
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Localisation

Coordinates

Primary address : 1 rue Anne de Pardieu25000 BESANCON Phone : 03 81 25 09 26 E-Mail : contact@cisteomedical.com

Advertising Région Bourgogne-Franche-Comté
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Modifer

General Information

  • Company name : CISTEO MEDICAL
  • NAF code : 7219Z
  • Juridical status : SAS
  • Date of creation : 2010
  • Social capital : 20 000€
  • Workforce : 44
  • Siret : 523 617 686 00028
  • Turnover (EXCL. VAT) : 3 787 000€
  • Turnover Export (EXCL. VAT) : 2 062 000€
  • Customer references : COUSIN SURGERY, MYOPOWERS, VYGON
  • Languages : Allemand, Anglais, Français
Responsables

Manager(s)

  • Responsable n°1

    M. Christophe MOUREAUX
    President

  • Responsable n°2

    M. Julien GAUTHIER
    Sales director

Software(s)

Minitab, Solidworks

Savoir-faire

Know-how(s)

  • Regulatory Affairs
  • Assembly in controlled atmosphere
  • Medical device design office
  • Design of connected medical devices
  • Design of implantable medical devices
  • Design of non implantable medical devices
  • Design and manufacture of electronic cards
  • Design and manufacturing of medical devices (class 2)
  • Design and manufacturing of medical devices (class 3)
  • Design and manufacturing of connected medical devices
  • Advice on certification
  • Consulting in homologation (CE marking)
  • Degreasing / Cleaning / Washing / (clean room)
  • Feasibility studies
  • Studies and development of test bench
  • Metallographic examination and chemical analysis
  • Manufacturing of medical devices (class 1)
  • Manufacturing of medical devices (class 2)
  • Manufacturing of medical devices (class 3)
  • Manufacturing of connected medical devices
  • Manufacturing of medical devices (ISO 5 room)
  • Manufacturing of medical devices (ISO 7 room)
  • Manufacturing of implantable medical devices
  • Manufacturing of non implantable medical devices
  • Industrialization of assembly processes by welding techniques
  • Silicone injection
  • Laser (welding)
  • Micro-assembly
  • High precision micro-injection
  • Nitinol shaping
  • Prototypes (medical devices)
  • Qualification of manufacturing processes
  • High frequency welding
  • Resistance welding
  • Welding under qualification
Industries

Destination industries

  • Biomedical
  • Medical
  • Health
Renseignements techniques

Technical information

MATERIALS WORKED ON

  • Elastomère (Silicone)
  • Nitinol
  • Polymères
  • Inox
  • Titane

MACHINERY AND EQUIPMENT

  • Salle blanche 200m²
  • Presse d'injection silicone MAPLAN
  • Installation de soudure laser 5 axes
  • Machines de soudure laser
  • Marquage laser
  • Traitement plasma
  • Contrôle dimensionnel optique KEYENCE
  • Métrologie traditionnelle
  • Machine de soudure haute-fréquence
Renseignements techniques

Certifications

  • 21 CFR part 820 FDA
  • Agrément CII
  • Agrément CIR
  • ISO 13485
  • ISO 13485 v 2016
  • Qualiopi

Observations

Specialised in development and manufacture under contract of medical devices, Cisteo MEDICAL can assist you in every stage of your projects : from the first proof of concept to manufacturing (www.cisteomedical.com).
Cisteo CONSULTING help you to create and implement your quality management system in compliance with ISO 13485 and/or 21 CFR part 820 and/or RIM. Our team can assist you in drafting and/or updating your regulatory files for European markets (EU Regulations 2017/745 and 2017/746) and also US, Canadian, Brazilian markets, etc. (www. cisteoconsulting.com).

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