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Declaration for compliant with RoHS II and REACH 209

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To protect critical neonatal patients from potentially hazardous substances and (Substance of Very High Concern, #SVHC), Create BiotechTM not only selects the safest materials, but also actively sends the “Neonatal Heated Wire Breathing Circuit, humidifier chamber and Neonatal CPAP” products to the 3rd party, the "Taiwan Testing and Certification Center" for conducting the validations of #RoHS II and #REACH 209.

RoHS stands for Restriction of Hazardous Substances and restricts the use of specific hazardous materials, including lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (CrVI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and four different phthalates (DEHP, BBP, BBP, DIBP).
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation. REACH addresses the production and use of chemical substances of very high concern (SVHC) because of their potential negative impacts on human health or the environment.

At the same time, we review and confirm the following products use the same material and the same manufacturing processes: Single-Use Flexible Breathing Circuit and Accessories. Heated Wire Breathing Circuit and Accessories. Humidifier Chamber Single-Use Extendable Breathing Circuit and Accessories. Bubble CPAP Nasal Cannula and Nasal Prongs nCPAP system, Nasal Mask, Nasal Prongs CPAP Cannula High Flow Nasal Cannula

We can assure our products are still safe after undergoing a complete production process. Contact info@create-biotech.com for more information.


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