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Declaration Conformity.pdf

declaration_of_conformity_regu-4019_rev_2021.pdf
Preview of Declaration Conformity
🔗 Source: kscdn-dev.azureedge.net
📊 Size: 137 KB
👤 Author: Lena Cordie
⬇️ Downloads: 149

Summary

Key Surgical LLC declares conformity of its medical devices to Council Directive 93/42/EEC (MDD) and applicable regulations. The products include:

1. Key Surgical Cannulas (Class I Sterile) - for wound irrigation
2. Key Surgical Cautery Tip Cleaner (Class I Sterile) - for cleaning
3. Key Surgical Electro Lube (Class IIa Sterile) - lubricant for instruments
4. Key Surgical K-Wire and Pin Covers (Class I Sterile) - protective tips for surgical instruments
5. Key Surgical Silicone Clamp Covers (Class IIa) - covers for clamps
6. Key Surgical Skin Markers (Class I Sterile) - for skin marking
7. Key Surgical Suture Booties (Class IIa) - protective tips for surgical instruments
8. Key Surgical Vascular Loops (Class IIa) - for vascular procedures

The company appoints Medical Device Safety Service (MDSS) as its European Authorized Representative. The Conformity Assessment Route is Annex V, with a certificate issued by BSI Group the Netherlands B.V. (CE 666820). The certificate was issued on July 19, 2021, by Coletta Cohara, Director of Quality and Regulatory Compliance.

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Description

Key Surgical LLC declares conformity of medical devices to EU regulations. Products meet MDD and ISO standards. Devices include cannulas for wound irrigation.

Technical Information

  • File Format: PDF
  • File Size: 137 KB
  • Pages: 2
  • Language: EN
  • Author: Lena Cordie
  • Total Downloads: 149
  • Last Updated: 1 month ago

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