Alert number: INFO/00182/20

Product:  Particle filter mask

Name: Medical mask with two layers

Barcode:  6422125003911
Batch number:  LHP – 1283 02/2028

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


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Phone +32 56 70 11 03 - email:

VAT: BE0454 000 382 - RPR Business Court Gent - Division Kortrijk
Transparency register EC: 91447653655-65

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