| Manufacturer: ESound Medical Device Co., LTD Manufacturer’s Address: High-Tech Medical Equipment Industrial Park, Changyuan County, 453400, China |
| Product Name : ESound FFP3 Mask Features:
FFP3 mask / respirator with CE full certification – highest safety for you. Our FFP3 masks / FFP3 respirators feature a high-quality 4-layer construction and a specially developed internal nose seal. This ensures an almost perfect seal of the mask to the face of the wearer. The horizontal elastics are adjustable in length and are not hooked behind the ears, but are guided around the head. This results in a particularly high wearing comfort, as the pressure on the ears, which is often felt to be very unpleasant, is eliminated. Our FFP3 respirators fache mask have a full CE certificate from a Notified Body and have passed all the necessary tests. They are also certified to EN 149:2001 + A1:2009 and are approved as personal protective equipment (PPE) according to EU regulations. We would be pleased to send you all certificates on request. If this is desired, please send a short email to info@esoundmd.com or support@esoundmd.com |
User Instruction:
Storage conditions: Store in a dry and clean warehouse with excellent ventilation and no corrosive gas where the relative humidity is less than 80%. |
| How can I recognise a genuine FFP3 mask? FFP3 masks are not medical devices, but so-called personal protective equipment (PPE). The properties of FFP3 respirators are regulated in the EU standard EN 149:2001+A1 :2009.The EU has accredited various institutes that are allowed to test such PPE. These so-called “Notified Bodies” are tested by the EU and are subject to strict regulations. Such institutes are for example TÜV and DEKRA in Germany, BSI in England.There are a whole range of other Notified Bodies, e.g. in Spain, Poland, Italy etc. It does not matter where a mask has been certified, as all notified bodies are strictly controlled. It is important that a mask has been checked by one of these notified bodies.How do I know that an FFP3 mask has been tested by an accredited institute of the EU? Every FFP3 mask that has been tested by an EU notified body and passed the test can and must have the CE mark printed on it. The CE mark must be followed by a four-digit number. This number allows you to find out at which institute the mask was tested. In order to identify a tested mask correctly, a mask must bear an article number in addition to the CE mark with the four-digit identification number of the testing institute. This mask is complied with FFP3 EN 149:2001+A1 :2009
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| References to Regulation & Technical Specification: Regulation: The European PPE Regulation (EU) 2016/425; |
| Module B & Module D (EU type-examination ) Notified Body details: AENOR INTERNACIONAL S.A.U. Génova, 6. 28004 Madrid. España Tel. 91 432 60 00.- www.aenor.com Notified Body No. 0099 |
Zaw Lin Tun –
Excellent services and product quality