Regulatory Coverage

Noble Biomaterials prides itself on its environmental awareness and a related commitment to pursuing sustainable paths for its technologies, facilities, and operations. These ideas are grounded firmly in Noble core values. Noble has embraced fundamental aspects of sustainability and has worked hard to ensure all requirements of environmental and regulatory agencies are not only met, but exceeded.

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US ENVIRONMENTAL PROTECTION AGENCY
Antimicrobial and Conformance Registrations

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US FOOD & DRUG ADMINISTRATION
Class 1 & 2 Medical Device Approvals

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Class 1, 2 & 3 Medical Device Approvals

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OEKO-TEX®
Standard 100 Certification

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BLUESIGN SYSTEM PARTER


X-STATIC® products, containing the active ingredient silver can be found in FDA cleared and CE-marked products used in a diverse portfolio of advanced wound care products. Additionally, X-STATIC® products are also registered with the United States Environmental Protection Agency (EPA) as antimicrobial products for the odor protection of finished treated articles.

  • bluesign® System Partner
  • EPA-Registered*
  • FDA Cleared
  • CE marked
  • Oeko-Tex Certification
*EPA Regulated products containing X-STATIC® solely protect the finished product itself from microbial growth. Any public health claims related to X-STATIC® products are expressly limited to products regulated by the FDA.

X-STATIC® for Healthcare

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