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High Precision CE Certified Infrared Thermometer for Human Use. FDA and CE MDR Certified: Obtained FDA 510(k), CE MDR, ISO 13485, and other authoritative certifications. OEM and ODM Services: Full customization available from samples, designs, or flexible options. ISO 13485 Compliant: Manufactured in a facility certified under ISO 13485 medical device standards. Global Market Reach: Exported to over 50 countries in Europe, Americas, Asia, and the Middle East. Advanced Production Base: 8,000+ square meter facility with 6 automated production lines. 100% Quality Inspection: Every product undergoes visual and functional inspection before shipping.