PRIMA — Medical mask with two layers
Green medical mask with two layers. Masks are described as Class 1 medical devices, but in the same time, as ,,General purpose face mask suitable for medical, food processing as well as industrial use."
- Risk level
- Other types of alerts
- Type
- Health risk / other
- Catégorie
- Protective equipment
- Risque
- 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.
- Origin
- People's Republic of China
⚖️ Actions ordonnées par les autorités
- ▸ (to: Retailer) Withdrawal of the product from market
6422125003911
What is this? PRIMA is a medical mask sold in Romania. It has two layers and a CE mark. The maker says it is a surgical mask, but it has not been checked by a European safety group.
What's happening? The mask may not meet safety rules. It might not protect you well unless you use other safety steps.
Does this affect me? If you bought or used this mask in Romania, it could affect you.
What should I do? Stop using the mask. Ask your pharmacist or doctor for advice on safe masks.
🤖 Ce résumé en langage clair est généré automatiquement à partir de l'avis officiel de l'agence à l'aide de l'IA. Il est fourni à titre d'information générale uniquement — il ne s'agit pas de conseils médicaux. Pour toute décision concernant votre santé, consultez toujours un pharmacien ou un médecin et lisez la source officielle liée ci-dessous.
🔬 Détails médicaux / techniques (pour les professionnels)
Risk level: Other types of alerts · Type: Health risk / other · Category: Protective equipment · Hazard: 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. · Origin: People's Republic of China
Toutes les informations de cette page proviennent de l'avis officiel de l'agence. Nous les traduisons et les résumons ; nous n'ajoutons ni ne modifions les faits.