REACH COMPLIANCE

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is a European Union Commission (EUC) Regulation No 1907/2006 on chemicals and their safe use. The REACH regulations became effective on June 1, 2007.

REACH establishes specific duties and obligations on a business in the European Union (EU) which manufactures or imports a substance or article that includes a “substance of very high concern” (SVHC) in concentrations of more than 0.1% w/w. A substance which is listed on the “Authorisation List” published by the European Chemicals Agency (ECHA) (Annex XIV of the REACH regulations) cannot be manufactured or imported in the EU.

Statement of Conformity

We herewith declare that all X-medics’ products are REACH-compliant to Regulation No 1907/2006. The products does not contain substances of very high concern (SVHC) listed in the Candidate list 23 January 2024 at concentrations above the listed threshold. The purity of X-medics products have further been verified by an independent ISO 17025 accredited laboratory who found no toxic substances released

ROHS Conformance

Directive 2015/863/EU

The RoHS-Directive 2015/863/EU of the European Parliament and of the Council restricts the use of the hazardous substances listed below in medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments.

The following substances and there limits are:

  • Lead (Pb): < 1000 ppm
  • Mercury (Hg): < 100 ppm
  • Cadmium (Cd): < 100 ppm
  • Hexavalent Chromium (Cr VI) < 1000 ppm
  • Polybrominated Biphenyls (PBB): 1000 ppm
  • Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
  • Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
  • Benzyl butyl phthalate (BBP): < 1000 ppm
  • Dibutyl phthalate (DBP): < 1000 ppm
  • Diisobutyl phthalate (DIBP): < 1000 ppm

Statement of ROHS Conformity

We herewith declare that all X-medics’ products are RoHS-compliant to Directive 2015/863/EU

The purity of X-medics products have further been verified by an independent ISO 17025 accredited laboratory who found no toxic substances released from is X-medics’ products by an evaluation for Cytotoxicity according to ISO 10993

29 October 2024

Bo Gillesberg
Quality and Regulatory Affairs Director

Disclaimer

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