Health warning in Spain for sanitary products detected with fake CE markings

An alert has been issued by AEMPS, the Spanish Agency for Medicines and Health Products, over the detection of a false CE certificate marking.

This labelling has been used to market health products in Spain without proper authorisation the government department explained in a statement on Thursday, June 8.

⚠️ La AEMPS informa sobre la detección de un certificado de marcado CE falso de la empresa Prolinx GmbH

➡️ Los productos afectados son tensiómetros, termómetros, succionador, nebulizadores, 'doppler' digital a color y audífonos de este fabricante

🔗 https://t.co/VGSoFhZHGo pic.twitter.com/aBjEps6bIc

— AEMPS (@AEMPSGOB) June 12, 2023

The counterfeit notice was communicated to Spain’s Ministry of Health by the German health authorities.

‘A false CE marking certificate with number 0483/N50569-14-7 has been detected, from the German notified body MDC Medical Device Certification GmbH, whose identification number is 0483 for the manufacturer Prolinx GmbH’, said the AEMPS statement.

It detailed that the products in question included: “blood pressure monitors, thermometers, a suction machine, nebulisers, digital colour Doppler and headphones’.

The certificate had an issuance date of December 8, 2019, with an expiration date of July 2, 2023. AEMPS added that the order was issued for ‘market control purposes’ so that the corresponding authorities could proceed to take the relevant measures.

What is a CE marking?

A CE marking is globally recognised as a symbol used on commercial products to show that the manufacturer or importer affirms the goods’ conformity with European health, safety, and environmental protection standards.

Having a CE label does not make is not a brand of origin. In other words, it does not mean that it has been manufactured in the European Union.

Rather, it implies that the product that has been placed on the EU market complies with European safety legislation. CE is an abbreviation of ‘conformité européenne”, which is French for ‘European conformity’.