Alert number: INFO/00182/20
Name: Medical mask with two layers
Type of alert: Other
Category: Protective equipment
Brand: PRIMA
Type / number of model:
Counterfeit: UNKNOWN
Risk type: Health risk / other
The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such by a relevant European body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. / The product does not comply with the requirements of the Medical Devices Directive and with the relevant European standard EN 14683.
Measures ordered by public authorities (to: Retailer): Withdrawal of the product from the market
Description: Green medical mask with two layers. Masks are described as Class 1 medical devices, but in the same time, as ,,General purpose face mask suitable for medical, food processing as well as industrial use."
Packaging description: The product is sold in a white and blue cardboard box containing 50 pieces.
Country of origin: People's Republic of China
Alert submitted by: Romania
