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Statement regarding medisana infrared thermometers (TM 300/310/320)


As a leading German medical devices company with over 40 years of history in innovation, medisana is committed to providing comprehensive personal health & care solutions to customers in over 40 countries worldwide. medisana has always been committed to supporting people’s health with the motto, “Your health in good hands”, and so product quality and safety have continually been the company’s upmost important considerations. All medisana medical products are produced to the highest quality standards and undergo rigorous quality control procedures by independent third parties, possessing attested certifications such as the EU Medical Device Directive (MDD) and certification by the Taiwan Food and Drug Administration (TFDA). At the same time, medisana products in the Asia-Pacific region are professionally selected to meet the needs of local customers. The infrared thermometer is a Class II medical device, and its quality level complies with medical device international regulatory requirements and meets the ISO 80601-2-56 standard. For many years, medisana has regularly provided product training and updated information on personal health & care management for distributors around the world, including the standard usage of electronic thermometers. At the same time, medisana also provides product manuals, instructions, and FAQs for all products to ensure customers to understand the standard usage of products. Regarding recent feedback from the Taiwan market concerning the accuracy of the infrared thermometer, medisana is treating the feedback with a high degree of concern and care and have recently appointed the world-leading certification company SGS to conduct tests on the three thermometers – TM 300, TM 310 and TM 320. The comprehensive test results showed that all three products have met the required standards, thereby reiterating their exceptional accuracy. Model no. TFDA Certificate SGS Test Report TM 300 Infrared Ear & Forehead Thermometer ( 衛部醫器陸輸字第001269號 Report no. GZES230400685001 TM 310 Clinical Infrared Thermometer ( 衛部醫器陸輸字第001270號 Report no. GZES230400685101 TM 320 Non-contact & Multi-functional Infrared Thermometer ( 衛部醫器陸輸字第001279號 Report no. GZES230400685201 medisana has been in close communication with its Taiwan distributor, Heng Leong Hang Co., Ltd. (Heng Leong Hang) (北市衛藥販(內)字第MD6201029927號). Heng Leong Hang has also assisted customers in solving product inquiry, including: Stock recovery, testing or replacement Customers can bring the purchase certificate or receipt to the channel from where they originally purchased the device for a replacement if the product is found to be defective. For customers without purchase certificates or a receipt, Heng Leong Hang will provide them with a new product after conducting testing. Inquiry medisana and Heng Leong Hang have set up dedicated customers service channels to assist customers with any enquiries they may have relating to the infrared electronic thermometer: A) Heng Leong Hang toll-free service hotline: 0800-251-209. (Please indicate that your call is regarding the Infrared Ear & Forehead Thermometer.) (2) Heng Leong Hang LINE customer service (@hlh0800251209): medisana product testing service i. Please click on the horizontal scrollable menu at the bottom and select “4. MEDISANA Customized Service”; ii. Select “Infrared Ear & Forehead Thermometer”; iii. Please provide your personal information and inquires. The customer service team will contact you as soon as possible. Product calibration In order to strengthen customers’ confidence, all products which are stock-recovered as part of the safety testing endeavor will be sent to medisana’s overseas third-party international testing center for testing and calibration. medisana is also discussing with local testing centers to introduce real-time testing services in the future for added convenience and reassurance relating to locally available products. medisana has extensive experience in the medical device industry and has strictly reviewed the product production procedure. medisana reaffirms its emphasis on the quality and safety of the products. Regarding the recent single incident, medisana apologizes for the inconvenience caused and thanks every customer for their feedback. medisana promises to take proactive measures to address the concerns and is committed to working with customers around the world to create a healthy life.