the National Administration of Medicines, Food and Medical Technology (ANMAT) An order prohibiting the immediate use, marketing, publication and distribution throughout the country Medical equipment specified in the models Dermotrap, AQUA and SIENNA, manufactured by DERMOEQUIPOS SRLThis was after it became clear that these devices lack health registration and pose risks to public health.
This measure became effective this morning after publication Ruling 8804/2025 In the Official Gazette.
According to the story, the decision came as a result of an examination conducted at a clinic on the street Mansilla at 2500in Autonomous City of Buenos Aires (CABA)Where the employees are Market control departmentwith members Crimes against health department of the city policeAct on my orders Criminal First Instance Prosecution, Violations and Misdemeanors No. 21.
At the scene, a man who identified himself as a doctor was identified gramHe admitted that he used the department to see patients and perform cosmetic procedures, such as post-surgical recovery, facial and body treatments, application of botulinum toxin, hyaluronic acid and mesotherapy.
During the inspection, several cabinets equipped as offices were found, as were two devices bearing the name Dermotherap, models AQUA and SIENNA, both without health registration data or clear manufacturing date.
The property owner, identified as gsmHe admitted that the place did not have a health permit. When asked by inspectors, GR was unable to provide documentation proving the origin of the equipment, although it later sent a 2013 invoice issued by Dermoikibus riyal. However, the investigation found that the manufacturing date of the devices was later than the invoice date provided, raising doubts about the traceability and legality of the products.
the I grow It was verified in its records system that the teams were not listed as licensed. By consulting the manufacturer and its employees Dermoikibus riyal He admitted that the AQUA and SIENNA models were manufactured by the company, but the corresponding health registration was never processed. In addition, the company reported that production of this equipment had stopped in January 2025, although it was marketed during 2024, and it provided sales invoices to various individuals during that period.
Thus, the market monitoring department in I grow He warned that there are similar duly registered products, such as PM 1088-36, intended for the treatment of cellulite and local obesity, and PM 1090-51, intended for facial rejuvenation and smoothing, both of which are in risk category 2. However, AQUA and SIENNA equipment is not registered, so its properties, functions and safety are unknown, which poses a risk to the health of users.
As the organization put it. “The characteristics, functions and safety of the equipment are unknown, it poses a health risk; and since it is possible that there are other similar products in the marketing or use phase, this is to protect potential buyers and users of the products in question.”A preventive ban was recommended.
The ruling also provides for the opening of a health summary against Dermoikibus riyal and its Technical Director, for the alleged violation of Articles 2 and 19 of Law No. 16463, which prohibits the preparation, possession, fractionation, circulation, distribution and delivery to the public of impure or illicit products, and Paragraphs 1 of Parts 1 and 3 of the Annex to ANMAT Ruling No. 64/25, which provides for the mandatory registration of all medicinal products on national territory.
“Registration of all medicinal products included in this Convention is mandatory. Registration is understood as the administrative procedure by which each State Party permits the marketing of a medicinal product on its national territory,” they stated.