Compliance Centre
Regulatory documentation
EU Declaration of ConformityDownload PDF
Certificate of Conformity
Links Medical Products, Inc. declares under its sole responsibility that the Silent Knight Pill Crushing System conforms with the applicable requirements of the EU Medical Device Regulation. The device bears the CE mark accordingly.
EU Declaration of Conformity (signed)
REF DOC-001-02 · Rev 02 · Effective 2026-06-02 · PDF · 0.24 MB
Declaration details
CE marked
- Manufacturer
- Links Medical Products, Inc.
- Address
- 15979 N 76th Street, Suite D, Scottsdale, AZ 85260, United States
- Manufacturer SRN
- US-MF-000021290
- EU Authorised Rep
- Cost Saving Solutions Europe Ltd, Unit 35 Centre Block, Docklands Innovation Park, East Wall Road, D03 E086, Dublin, Ireland
- EU REP SRN
- IE-AR-000016085
- Device
- Silent Knight Pill Crushing System & genuine pouches
- Classification
- Class I Medical Device (Rule 1, MDR Annex VIII)
- Legislation
- Regulation (EU) 2017/745 (MDR)
- Conformity route
- Article 52(7), MDR — self-declaration (Annexes II, III & IV)
- Notified Body
- Not applicable — Class I self-declaration
- Approved by
- Gary Chilson, QA/RA Manager
Applied standards
- EN ISO 13485:2016 — Quality management systems for medical devices
- ISO 14971:2019 — Application of risk management to medical devices
- EN ISO 15223-1:2021 — Symbols to be used with information supplied by the manufacturer
- EN ISO 20417:2021 — Information to be supplied by the manufacturer
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