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SAFETY GATEReference INFO/00182/20

Medical mask with two layers — health risk / other

Descriptive title organised by NagameAlert; the official wording is available from the source.

Official information organised for easier consultation. The source publication remains authoritative.

Identification

Product identification

Product
Medical mask with two layers
Brand
PRIMA
Category
Protective equipment
Lot/s
6422125003911 · LHP – 1283 02/2028
Product domain
Non-foodNagameAlert treatment

Official information

Risk and measures

Risk or hazard
Health risk / other
Official description
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
Type of economic operator to whom the measure(s) were ordered: RetailerCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: 04/11/2020

Territory

Geography

Origin
People's Republic of China
Notifying country or territory
Romania
Distribution
Notificado por Romania

Provenance and context

NagameAlert distinguishes content published by the source from its organisation and normalisation. Values marked “NagameAlert” belong to that processing layer. Always check measures, scope and updates in the official publication.