ELIS SHPK, myfixmask — N95/FFP2 respirator, N95/FFP2 mask
Protective respiratory filtration half-face mask. Models 001 and 002 cannot be distinguished from each other on the basis of the printed labelling or the barcodes. Furthermore, the masks' labels differ from one mask to another and are not uniform. The product is also sold online.
- Risk level
- Serious risk
- Tipo
- Health risk / other
- Categoria
- Protective equipment
- Perigo
- The particle/filter retention of the material is insufficient (measured value as low as 49%). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. As a result of the labelling, the mask may be worn in areas where hazardous substances are in use or during activities involving asbestos; since the mask fails to offer sufficient protection, this could lead to asbestosis, with fatal consequences.
- Origin
- Unknown
⚖️ Ações ordenadas pelas autoridades
- ▸ (to: Other) Marking the product with appropriate warnings on the risks
- ▸ Measures ordered by economic operators (to: Importer) Import rejected at border
- ▸ (to: Other) Destruction of the product
3901501930018
3901501930049
What is this? This is a face mask called ELIS SHPK or myfixmask. It is sold as an N95 or FFP2 mask to protect against small particles.
What's happening? Tests show the mask does not filter enough particles. It may let in too many harmful particles or germs. This could raise the risk of infection.
Does this affect me? If you own or use this mask in Germany, it may not protect you well. It could be especially risky if used around dangerous substances like asbestos.
What should I do? Stop using the mask and ask your pharmacist or doctor for advice on safer masks.
🤖 Este resumo em linguagem simples é gerado automaticamente a partir do comunicado oficial da agência, com recurso a IA. Destina-se apenas a fins informativos — não constitui aconselhamento médico. Para tomar decisões sobre a sua saúde, consulte sempre um farmacêutico ou médico e leia a fonte oficial vinculada abaixo.
🔬 Detalhes médicos/técnicos (para profissionais)
Risk level: Serious risk · Type: Health risk / other · Category: Protective equipment · Hazard: The particle/filter retention of the material is insufficient (measured value as low as 49%). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. As a result of the labelling, the mask may be worn in areas where hazardous substances are in use or during activities involving asbestos; since the mask fails to offer sufficient protection, this could lead to asbestosis, with fatal consequences. · Origin: Unknown
Todas as informações desta página são provenientes do comunicado oficial da agência. Nós as traduzimos e resumimos; não adicionamos nem editamos factos.