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A11/00016/21

Particle filter mask

ELMED · DISPOSABLE FACE MASKS

Protective equipmentHealth risk / other
Country of origin
Türkiye
Notifying country
Romania
Sold online
No
Open the alert on the European Commission website ↗

What is the danger

The product bears a CE marking but is not certified as protective equipment by a relevant body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. Also, the labeling is confusing because on the cardboard box the mask is declared a “non-medical” one , while in the same time is mentioned the standard EN 14683: 2019.

Requirements breached

The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.

Measures taken

  1. Ban on the marketing of the product and any accompanying measures Compulsory measuresTaken by: ImporterIn force from: 27 October 2020

Product

Description
Non-medical disposable protective mask, 3 layers of protection.
Packaging
The product is sold in a white, blue and red cardboard box containing 50 pieces wrapped in a transparent plastic bag. The cardboard box is CE marked.
Brand
ELMED
Model / type
TP-MSK-013 (Non Sterile)
Barcode
8681371811345
Batch
TMSK013-2033

Original source

Data comes from the official Safety Gate system of the European Commission.

Alert number
A11/00016/21 ↗
Weekly report
Report-2021-9
Published
1 March 2021
Modified
1 March 2021

© European Union, Safety Gate · https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10002488

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