Omnimate holds FDA, ISO 13485, CE MDD, QMS, and international certifications ensuring highest quality medical device manufacturing standards globally.
Omnimate holds FDA, ISO 13485, CE MDD, and QMS certifications with 28 years of proven manufacturing excellence. Our comprehensive quality control system (IQC, IPQC, FQC with AQL 1.0 S4 compliance) ensures every anesthesia mask, laryngeal mask, and endotracheal tube meets the highest international safety standards. Request our certification documentation and quality assurance specifications to confirm your equipment meets all regulatory requirements.
Our extensive certification portfolio directly reflects our manufacturing capabilities and quality assurance commitment. We trust our product quality so thoroughly that we continuously expand our regulatory approvals to access new markets and serve healthcare providers globally. From anesthesia masks and laryngeal masks to endotracheal tubes, emergency masks, nasopharyngeal airways, laryngoscopes, resuscitators, and specialized devices like MIRAD (Mucosal Intranasal Rapid Atomization Devices), every product undergoes rigorous testing and validation. Combined with our EO sterilization services and custom medical component manufacturing, Omnimate delivers end-to-end solutions backed by experienced R&D teams and flexible customization capabilities. Partner with a certified manufacturer that prioritizes your regulatory requirements and product quality—contact our international sales team today to discuss your medical device sourcing needs.