Regulatory Compliance and Certifications

Aseptico’s certifications and regulatory compliance support the quality and reputability of our products and practices. We make it a priority to invest in quality systems and processes approved by the U.S. Food and Drug Administration (FDA) and other regulatory entities to ensure operator and patient safety. Our certifications include:

FDA
FDA compliance is required by the U.S. Food and Drug Administration (FDA) in order for manufacturers of medical devices to legally sell their products in the U.S. All of our medical devices have appropriate FDA Listings and 510(k) clearance to support their legal distribution within the U.S.
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UL/ETL
UL/ETL certification signifies that a device has been tested by an OSHA-approved Nationally Recognized Testing Lab (NRTL) for electrical, mechanical, and fire safety. Most hospitals and other institutions require equipment to carry these certifications to meet federal law and insurance requirements.
ISO 13485
ISO certification guarantees that a manufacturer has a recognized Quality Management System (QMS) in place. Aseptico is audited annually to ensure our design and manufacturing methods support our Quality Objectives and the regulatory requirements of countries that require this certification.
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CE
CE certification is a product certification in Europe that includes product reviews and quality system requirements. It is required for a product to be sold or used in the 27 member countries of the European Union, and many other countries recognize it as a sign of quality and safety.
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FDA Certificate to Foreign Government
CE certification is a product certification in Europe that includes product reviews and quality system requirements. It is required for a product to be sold or used in the 27 member countries of the European Union, and many other countries recognize it as a sign of quality and safety.
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MDSAP
MDSAP is a program that helps medical device manufacturers satisfy the requirements of multiple regulatory jurisdictions.
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8333 216th St SE
Woodinville, WA 98072 USA
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