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The Food and Drug Administration (FDA) informs all healthcare professionals and the public that the medical device products mentioned above has Certificate of Exemption (CoE) issued to Hisamitsu Pharmaceutical Co., Inc., Marketing Authorization Holder. Based on FDA Circular No. 2020-001 all Certificate of Exemption for Class A medical devices issued from 25 February 2014 shall remain valid until 03 November 2021 or within 2 years from date of effectivity of this Circular whichever is earlier.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2020-2184 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 unnotified medical device products, the online reporting facility, eReport can be accessed at

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 befindings of any violation of the company to the existing laws, rules and regulations

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-2184-A