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UK Declaration Of Conformity.pdf?

uk_doc_ra-39-and-ra-41_declaration-of-conformity-class-i-uk-mdr-2002_sterilization_wrap.pdf
Preview of UK Declaration of Conformity
🔗 Source: kscdn-dev.azureedge.net
📊 Size: 340 KB
👤 Author: Saldukas, Berta
⬇️ Downloads: 144

Summary

Key Surgical LLC declares conformity of their Sterilization Wrap & Transportation Wrap and Covers to the UK Medical Devices Regulations 2002. The products are classified as Class I non-sterile, non-measuring devices. The declaration is based on self-certification under Annex VII.

The products have been assessed for conformity and meet the relevant requirements. The manufacturer holds ISO 13485 certification (MD 666821) with an expiry date of May 11, 2023. UKCA marking started on November 10, 2022.

A list of applicable SKUs is provided in Appendix A, including various sterilization wraps and transportation wraps with different item numbers. The products are designed for single-use sterilization packaging.

The declaration was issued by Steve Deline, Manager of Regulatory Affairs, on November 9, 2022, in Eden Prairie, MN, USA. The document is part of the SCS-148-TM-008 Declaration of Conformity Template, Version 1, for UK MDR Class I non-sterile, non-measuring devices.

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Description

Key Surgical LLC declares conformity of Sterilization Wrap & Transportation Wrap and Covers to UK Medical Devices Regulations 2002. The product is classified as Class I non-sterile, non-measuring. Conformity is self-certified under Annex VII.

Technical Information

  • File Format: PDF?
  • File Size: 340 KB
  • Pages: 5
  • Language: EN
  • Author: Saldukas, Berta
  • Total Downloads: 144
  • Last Updated: 3 weeks ago

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