The AEMPS has obtained a communication from the Slovak well being authorities of this product manufactured in Russia. It is the intragastric balloon from the producer JSC MediStars (Russia) that has a counterfeit stamp with a difficulty date of April 26, 2019 and expiration date of April 25, 2024. These gadgets are implanted on the hospital stage but in addition in non-public aesthetic clinics
The Spanish Agency for Medicines and Health Products (AEMPS) has reported on Tuesday the detection of silicone gadgets for gastric restriction with a falsified EC certificates, as reported by the Slovak well being authorities, which have warned of this product manufactured in Russia.
In this case, the affected product is the set of silicone gadgets for gastric restriction (MediStars intragastric balloon from the producer JSC MediStars, Russia) that has a counterfeit stamp with a difficulty date of April 26, 2019 and expiration date of April 25, 2024.
In the assertion, the AEMPS recollects that medical gadgets should be licensed by a notified physique and with the CE market seal in order that they are often marketed all through Europe.
Likewise, the Slovak well being authorities inform that the aforementioned notified physique 3EC International as (2265) issued a legitimate CE marking certificates with the identical quantity 2019-MDD/QS-033 for a unique firm, masking completely different medical gadgets, and never for the producer JSC MediStars, Russia, because it seems on the solid doc. However, this CE marking certificates ceased to be legitimate on November 1, 2022.
According to the AEMPS, this data is communicated for market management functions. These gadgets are implanted on the hospital stage but in addition in non-public aesthetic clinics.