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Certifications & Compliance
SULIXA Industries works with a certified manufacturing partner holding CE marking and ISO 13485 certification. CONFIRM exact certificate scope, number, and legal holder to be confirmed before publishing specific claims.
Full compliance documentation is available on request for bulk and distributor orders — see the Request an Instrument Quote page to ask for CE declarations, ISO certification, or batch traceability records with your enquiry.
CE / ISO 13485 documentation graphic
What does CE marking mean?
CE marking indicates a product meets EU health, safety, and environmental protection requirements and can be legally sold within the European Economic Area.
What is ISO 13485?
ISO 13485 is the international quality management standard specific to medical devices, covering design, production, and regulatory compliance throughout the manufacturing process.
How do I request documentation for a bulk order?
Use the Request an Instrument Quote form and note the documentation you need — CE declarations, ISO certification, or batch traceability records are available on request for distributor and hospital orders.