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Product catalog summary
EU Type-Examination Certificate Overview
This document is an EU Type-Examination Certificate issued by SGS Fimko Ltd, a Notified Body (0598) under the Personal Protective Equipment Regulation (EU) 2016/425, Module B. It certifies that the X-ray protective clothing, specifically the X-Ray Protective Apparel by Flow Dental, complies with essential health and safety requirements.

Product Specifications
The certified product includes various styles of X-ray protective apparel made from lead vinyl material, designed for dental use. The protection level is specified as 0.35mm lead equivalence at 80 kVp. The styles include:
  • Adult bib apron without collar (Product code: 75050)
  • Adult bib apron with attached collar (Product code: 75051)
  • Children’s bib apron without collar (Product code: 75053)
  • Thyroid collar for adult bib apron (Product code: 75056)
  • Panoramic apron (Product code: 75061)
  • CBCT Pano cape with collar (Product code: 75090)
  • CBCT Pano cape without collar (Product code: 75091)
All items are available in one nominal size.

Compliance and Standards
The product complies with the applicable standards based on IEC 61331-3:2014 and IEC 61331-1:2014, using the broad beam method as per RFU sheet PPE-R/05.34-001. The certificate is valid until August 11, 2027, and should be used with conformity assessment procedure module C2 or D.

Additional Information
The certificate is issued under the general conditions of service of SGS, with limitations of liability and jurisdiction issues defined therein. Unauthorized alterations or falsifications of the document are unlawful.

Contract and Technical Details
Contract No: GB-CERT220900450. Full assessment details are provided in Technical file: TF-0700-002, Rev 3, dated August 23, 2022.
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Catalog excerpts

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EU TYPE-EXAMINATION CERTIFICATE Regulation (EU) 2016/425, MODULE B 0598/PPE/22/3447 Issue 2 Product X-ray protective clothing X-Ray Protective Apparel Flow Dental Certificate Holder / Manufacturer Wolf X-Ray Corp. and Flow X-Ray Corp. dba Flow Dental 133 Wolf Road, 27809, Battleboro, North Carolina, United States of America Product complies with the applicable essential health and safety requirements of Regulation (EU) 2016/425 and standard(s) mentioned below Other Information Manufacturer’s technical specification (based on IEC 61331-3:2014 (Protective devices against diagnostic medical X-radiation – Part 3: Protective clothing and protective devices for gonads.) and on testing to IEC 61331-1:2014 broad beam method as per rfu sheet PPE-R/05.34-001) This certificate shall be used in conjunction with conformity assessment procedure module C2 or D. This certificate is valid until 2027-08-11. Kelvin Shepherd SGS Fimko Ltd is a Notified Body (0598) according to the Personal Protective Equipment Regulation (EU) Page 1 of 2 This document is issued by the Company under its General Conditions of Service accessible at http://www.sgs.com/terms_and_conditions.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of t

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Page 2 of 2 to Certificate: Additional information X-Ray protective apparel, manufactured from lead vinyl material, providing protection to parts of the body for dental use available in the following styles with the lead equivalences 0.35mm at 80 kVp: Adult bib apron without collar, product code:75050; Adult bib apron with attached collar, product code:75051; Children’s bib apron without collar, product code:75053; Thyroid collar for adult bib apron, product code:75056; Panoramic apron, product code: 75061; CBCT Pano cape with collar, product code: 75090; CBCT Pano cape without collar, product...

 Open the catalog to page 2

All Flow Dental catalogs and technical brochures

  1. catalog

    28  Pages

  2. Film CE MDD

    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.