Truer Medical Earns CE Mark for Medical Devices

Officials from Truer Medical Inc., a leading manufacturer of quality temperature management disposables, intubation stylets, and gas sampling lines announce the receipt of the CE Mark for Medical Devices in Class IIa, Class Im/Is and Class I.

Truer Medical received the CE 0473 Mark for a wide range of products, including oesophageal stethoscopes, probes, skin and tympanic sensors, general purpose probes with temperature sensors, and accessories for monitoring temperature, heart and respiration activities of anaesthetized patients, and intubation bougies for assisted respiration during surgery.

“With the awarding of this mark, we now meet the regulatory requirements for exporting to the European Communities, Canada, Australia, New Zealand and any country accepting the CE mark for Medical Devices in Class IIa, Class Im/Is and Class I,” states Tim Truitt, president of Truer Medical Inc. “We welcome international inquiries for our quality medical products and look forward to working with our international distributors and customers.”

Located in Orange, CA, Truer Medical Inc. is a contract manufacturing and product development company dedicated to providing the highest quality medical device products in the industry. They are FDA registered, ISO 13485:2003 certified and MDD European compliant registered by Notifying Body CE0473. They provide engineering design capabilities to assist companies in developing custom medical products from concept, through design and 510K registration, and ISO/CE inclusion under a Certified Quality Management System.