The Food and Drug Administration (FDA) informs all healthcare professionals and the public that the medical device product “Surgitech Clinical Fieber Thermometer MT-101” has been registered by the Market Authorization Holder (MAH), Medasia Medical Product Corporation, with FDA registration number DVR-8795 in accordance to FDA rules and regulations.
Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2019-525 is hereby lifted.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unregistered medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules and regulation.
Dissemination of this advisory to all concerned is hereby requested.