Alert number: INFO/00180/20

Product:  Particle filter mask

Name: Face Mask Surgical Disposable

Barcode:  Unknown
Batch number:  Unknown

Type of alert: Other

Category: Protective equipment

Brand: 

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 of the relevant European standard EN 14683.

 

Measures ordered by public authorities (to: Importer): Withdrawal of the product from the market

 

Description:  Face mask surgical disposable.

Packaging description:  The masks are packed in a white and blue cardboard box containing 50 pieces with the product description in English with black characters. The packaging bears the CE marking.

Country of origin: People's Republic of China

Alert submitted by: Romania

 

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Disclamer ESF

The information contained in this communication (letter, e-mail, on the ESF website or in documents available for download on the ESF website or as attachment to letter or e-mail, etc..) is intended for guidance only and whilst the information is provided in utmost good faith and has been based on the best information currently available, is to be relied upon at the users own risk.ESF will not accept any direct or indirect liability deriving from it. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted for damages of any nature whatsoever resulting from the use of or reliance on the information. The guidance is based on available legislation and information and the interpretation of that legislation/information by ESF. Each company based on its own decision-making process may decide to use the guidance in full, partially or not, as it suits its needs but no liability shall be attributable to ESF.
   

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