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Baitella-FISSO-General-POP-Declaration

Baitella-FISSO-General-POP-Declaration
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Baitella-FISSO-General-POP-Declaration

Product catalog summary
Declaration of Conformity Overview
This document is a Declaration of Conformity issued by Baitella AG, a Swiss manufacturer, in accordance with the Medical Devices Regulations 2002 and the Medical Devices (Amendment; EU Exit) Regulations 2020. The declaration pertains to FISSO medical articulated arms with quick central fixation and components.
Manufacturer and Representative Details
  • Manufacturer: Baitella AG, Thurgauerstrasse 70, CH-8050 Zürich, Switzerland
  • UK Representative: confinis (UK) RP Ltd, St John's Innovation Centre, Cambridge, England
Product Information
  • GMDN Codes and Terms: The document lists several GMDN codes and corresponding terms such as arm procedure positioner, operating table patient positioning set, medical device service rail clamp, surgical instrument assist arm, breathing circuit tube holder, and blood pressure transducer holder.
  • Basic UDI: Unique Device Identifiers are provided for each product category.
  • Reference Numbers: Specific reference numbers are associated with each product type.
Compliance and Validity
  • The products are classified as Class I medical devices and meet all applicable provisions.
  • The validity of this Declaration of Conformity extends until March 15, 2029.
Signatories
  • Edgar Schönbächler, CEO
  • Juan Rubiano, QM/RA Manager & PRRC
Document Details
  • Document ID: TD0000123_D
  • Creation and Print Date: March 16, 2026
  • Template: ENHD Konformitätserklärung Index G, valid from April 20, 2022
See more

Catalog excerpts

Baitella-FISSO-General-POP-Declaration-1

Simply the best fixation. We as manufacturer according the Medical Devices regulations 2002 and the Medical Devices (Amendment; EU Exit) Regulations 2020 Baitella AG, Thurgauerstrasse 70, CH-8050 Zurich SRN: CH-MF-000017307 with Authorised UK Representative, confinis (UK) RP Ltd St John’s Innovation Centre Coweley Road, Cambridge CB4 OWS England, United Kingdom We declare under our sole responsibility that FISSO medical articulated arms with quick central fixation and components of class I meets all applicable provisions. Validity of this Declaration of Conformity until March 15, 2029 Juan Rubiano QM/RA Manager & PRRC Datei TD0000123_D- Konformitatserklarung UK \ Ersteller RJ \ gespeichert 2026-03-16 \ gedruckt 2026-03-16 Vorlage ENHD Konformitatserklarung Index G \ Ersteller AH \ Gultig ab 20.04.2022

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All FISSO catalogs and technical brochures

  1. Certificate ISO 13485 Baitella AG
    Certificate ISO 13485 Baitella AG

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  2. Baitella-General-RoHS-Declaration
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  3. Baitella-FISSO-General-REACH-Declaration
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  4. Baitella-FISSO-Declaration-of-Conformity
    Baitella-FISSO-Declaration-of-Conformity

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  5. Baitella-FISSO-Konformitaetserklaerung
    Baitella-FISSO-Konformitaetserklaerung

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  6. Certificate-ISO-9001-Baitella-AG
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  7. FISSO-Pressure-Transducer-Holders
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  8. FISSO-Surgery-Quick-Release-System-OEM
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  9. FISSO-Surgery-Quick-Release-System
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  10. FISSO-Surgery-Holders
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  11. FISSO-Respiratory-and-Anaesthetic-Tube-Holder
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  12. FISSO-Machine-Vision
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  13. FISSO_Cat_EN_
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  14. FISSO Patient Positioning Products
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  15. FISSO Patient Positioning System
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Archived catalogs

  1. FISSO Quick Release for OEM
    FISSO Quick Release for OEM

    1  Page

  2. FISSO Surgery
    FISSO Surgery

    2  Pages

  3. FISSO Quick Release
    FISSO Quick Release

    2  Pages

  4. FISSO Universal Applications
    FISSO Universal Applications

    2  Pages

  5. FISSO Surgery Radial Rail Clamp
    FISSO Surgery Radial Rail Clamp

    1  Page

  6. FISSO Breathing Circuit Holder
    FISSO Breathing Circuit Holder

    2  Pages

  7. FISSO Surgery Double Arm Holders
    FISSO Surgery Double Arm Holders

    1  Page

  8. FISSO Surgery Endoscope Holders
    FISSO Surgery Endoscope Holders

    1  Page

  9. FISSO Pressure Transducer Plate Holder
    FISSO Pressure Transducer Plate Holder

    1  Page

  10. FISSO Patient Positioning
    FISSO Patient Positioning

    2  Pages

  11. FISSO Heart Lung Machine
    FISSO Heart Lung Machine

    2  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.
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