The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the following medical device products have been registered by the Market Authorization Holder, OMM Healthcare Philippines Corporation, in accordance to existing FDA rules and regulations:
1. NIPRO SYNTHETIC HOLLOW FIBER DIALYZER ELISIO™ 190HR
2. NIPRO ELISIO™ – 17H SYNTHETIC HOLLOW FIBER POLYNEPHRON
Accordingly, the warning against the purchase and use of the subject medical device products as mentioned in FDA Advisory No. 2020-1691 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 regulations.
Dissemination of this advisory to all concerned is hereby requested.