{"lang":"en","id":10002488,"reference":"A11/00016/21","notification_type":"A11","published":"2021-03-01T16:46:43.699Z","modified":"2021-03-01T16:46:44.228Z","weekly_report":"Report-2021-9","title":{"text":"Particle filter mask","en":"Particle filter mask","translated":false},"name":{"text":"Particle filter mask","en":"Particle filter mask","translated":false},"name_specific":"DISPOSABLE FACE MASKS","brands":["ELMED"],"models":["TP-MSK-013 (Non Sterile)"],"barcodes":["8681371811345"],"batches":["TMSK013-2033"],"category":{"key":"protective.equipment","source_key":"product.category.protective.equipment","label":"Protective equipment","en":"Protective equipment","translated":false},"category_other":null,"risks":[{"key":"health.risk.or.other","source_key":"riskType.health.risk.or.other","label":"Health risk / other","en":"Health risk / other","translated":false}],"risk_other":null,"risk_description":{"text":"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.","en":"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.","translated":false},"legal_provisions":{"text":"The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.","en":"The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.","translated":false},"description":{"text":"Non-medical disposable protective mask, 3 layers of protection.","en":"Non-medical disposable protective mask, 3 layers of protection.","translated":false},"packaging":{"text":"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.","en":"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.","translated":false},"origin_country":{"code":"TR","label":"Türkiye","en":"Türkiye","translated":false},"notifying_country":{"code":"RO","label":"Romania","en":"Romania","translated":false},"counterfeit":null,"sold_online":{"key":"option.no","source_key":"option.no","label":"No","en":"No","translated":false},"online_trader":null,"professional_use":false,"corrigendum":null,"measures":[{"category":{"key":"measure.category.ban.on.marketing.of.product","source_key":"measure.category.ban.on.marketing.of.product","label":"Ban on the marketing of the product and any accompanying measures","en":"Ban on the marketing of the product and any accompanying measures","translated":false},"details":null,"type":{"key":"measure.type.compulsory","source_key":"measure.type.compulsory","label":"Compulsory measures","en":"Compulsory measures","translated":false},"taken_by":{"key":"measure.operator.importer","source_key":"measure.operator.importer","label":"Importer","en":"Importer","translated":false},"effective":"2020-10-27"}],"photos":[{"id":10025899,"thumb":"https://cdn.weblocally.com/safety-gate/10002488/10025899-t.webp","full":"https://cdn.weblocally.com/safety-gate/10002488/10025899-f.webp"},{"id":10025900,"thumb":"https://cdn.weblocally.com/safety-gate/10002488/10025900-t.webp","full":"https://cdn.weblocally.com/safety-gate/10002488/10025900-f.webp"},{"id":10025901,"thumb":"https://cdn.weblocally.com/safety-gate/10002488/10025901-t.webp","full":"https://cdn.weblocally.com/safety-gate/10002488/10025901-f.webp"},{"id":10025902,"thumb":"https://cdn.weblocally.com/safety-gate/10002488/10025902-t.webp","full":"https://cdn.weblocally.com/safety-gate/10002488/10025902-f.webp"}],"url":"https://safety.weblocally.com/en/alert/10002488","api_url":"https://safety.weblocally.com/api/v1/alerts/10002488?lang=en","source_url":"https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10002488","license":"Data © European Union, Safety Gate. Reuse authorised provided the source is acknowledged."}