The Food and Drug Administration (FDA) advises the public from purchasing and using the counterfeit medical device:
The FDA has coordinated with the Market Authorization Holder (MAH), AMB HK Enterprises Inc., and has verified that the aforementioned medical device is COUNTERFEIT. The MAH stated that they are not responsible for the importation and distribution of the above-mentioned counterfeit medical device product.
Counterfeit products did not go through the required safety assessment and the FDA verification process. These products pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed.
In light of the foregoing, the public is advised not to purchase the aforementioned violative products.
All concerned establishments are warned not to distribute counterfeit medical device.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.
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, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA-Advisory-No.2021-0524