01.08.2025
To the attention of all interested persons
The NAMMDR warns of the withdrawal of the EC certification for Los Deline – hydrophilic gel for the process of using implants (endoprostheses) of the soft tissues of the human body, Biotr producer S.R.O., the Czech Republic. This medical device is an injectable, non-absorbable product, based on Copoliamide, used mainly for aesthetic purposes, to increase body volume, breasts and buttocks.
Withdrawal of the EC certification was decided by the notified body on 02.05.2023, following the unsatisfactory results of an intracutaneous reactivity test.
According to the information received by the NAMMDR, after the certificates withdrawal, by field safety notification FSN-23-002-pr, the manufacturer Biotrh S.R.O., the Czech Republic requested the withdrawal of all Los Deline 100g which remained unused, which were supposedly still present in the following states: Germany, Germany, Germany, Italy, Greece, Turkey, Switzerland, Cyprus, France and Norway.
The deadline for withdrawal of these devices from the EU was 30 November 2023, but given the validity period of these devices (3 years) and the fact that they were also marketed in non-EU countries, from where they can enter the EU territory, the NAMMDR recommends both healthcare professionals and patients to be extremely cautious and, if they have come into possession of such devices or are aware of distributors who sell these products on Romanian territory, to not use them and notify the National Agency for Medicines and Medical Devices of Romania – the market surveillance service at the contact details posted on the NAMMDR website.