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Regulation (EU) 2017/745

Regulation (EU) 2017/745

Product catalog summary
Certificate Overview
Bureau Veritas Italia S.p.A. has issued a quality assurance certificate to SIMPLE & SMART SRL, located at VIA PEROLA, 16 – 24021 ALBINO (BG) - ITALY. The certified production site is VIA SAN CARLO 33/35 – 24029 VERTOVA (BG) - ITALY.
Regulatory Compliance
The certificate confirms compliance with Regulation (EU) 2017/745, specifically annex XI part A, for the production quality assurance system of the manufacturer.
Medical Devices Covered
The certificate pertains to the following medical devices: SS_ONE, SS_KISS, SS_ITALO, which are categorized as active non-implantable dental devices under the generic group 'Dental unit' with a risk class of IIa.
Certificate Details
Certificate Number: IT337342, Version: 1, Issue Date: 14/11/2024. The certificate is valid until 13/11/2029, subject to continued satisfactory operation of the quality assurance system.
Additional Information
The certificate was issued by Bureau Veritas Italia S.p.A., a notified body under Regulation (EU) 2017/745 with identification number 1370. Examination and test details, along with relevant reports, are available upon request.
Unique Device Identifier
Basic UDI-DI: 805776025FT01SSC7
Conditions and Limitations
There are no specific conditions or limitations on the validity of the certificate.
Revision History
First issue approval on 14/11/2024, Revision n. IT337342-1.
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Catalog excerpts

Regulation (EU) 2017/745-1

Bureau Veritas Certification EU quality assurance certificate Issued to VIA PEROLA, 16 - 24021 ALBINO (BG) - ITALY Single Registration number: IT-MF-000029732 Certified site(s) VIA SAN CARLO 33/35 - 24029 VERTOVA (BG) - ITALY Bureau Veritas Italia S.p.A. certifies that the production quality assurance system of the above mentioned manufacturer has been audited and it complies with the requirements of (in accordance with annex XIpart A) In relation to the following Medical Device(s): This certificate is issued by Bureau Veritas Italia S.p.A. Viale Monza 375- 20126 Milano ITALY, notified body according to the Regulation (EU) 2017/745 with identification number 1370. Information on examinations and tests performed regarding relevant CS and harmonized standards, relevant test reports and audit report(s) are in the dossier (FLEX n. 17773484) available on request from [email protected]

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All SIMPLE&SMART catalogs and technical brochures

  1. MACHINERY

    14  Pages

  2. SURGERY

    36  Pages

  3. SS-ITALO

    44  Pages

  4. SS-KISS

    36  Pages

  5. SS-ONE

    36  Pages

  6. HYGIENE

    32  Pages

  7. TREATMENT UNITS

    20  Pages

  8. RADIOLOGY

    13  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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