23.12.2021
To the attention of all users/distributors of PRP Blood Collection Tubes (Platelet Rich Plasma) / manufacturer ANHUI SINIC LABORATORY MEDICINE TECHNOLOGY CO. LTD., China
The National Agency for Medicines and Medical Devices of Romania warns all users and distributors of PRP Collection Tubes (Platelet Rich Plasma) products manufactured by ANHUI SINIC LABORATORY MEDICINE TECHNOLOGY CO. LTD., China to immediately stop their use or placing them on the market, since their introduction on the EU market was carried out on the basis of falsified compliance documents.
If you have acquired these products – PRP (Sodium Heparin), PRP (Sodium citrate + gel), PRP (Sodium citrate + gel + hyaluronic acid) or any other type of PRP Blood Collection Tubes of this manufacturer, accompanied by the attached documents, do not use them or make them available on the market and notify the Market Surveillance Service of the National Agency for Medicines and Medical Devices of Romania (see the contact details on the NAMMDR website).
In order to prevent the introduction of non-compliant medical devices which do not comply with the applicable regulatory requirements into the legal distribution chain, particularly in the context of the COVID-19 pandemic, please exercise maximum caution, constantly consult the website of the National Agency for Medicines and Medical Devices of Romania for such information and make sure that the products you purchase come from distributors approved by our institution, in accordance with the provisions of Article 926 of Law 95/2006 on healthcare reform, republished, with further amendments and supplementations.
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