Strong filtration. Easy breathing. Without compromise.
We manufacture the FFP2 NR respirator for hospitals, pharmacies, distributors and businesses across Europe. Certified to EN 149:2001+A1:2009 under notified body CE 2890, tested batch by batch, and delivered EU-wide in three to five days.
- 3 to 5 daysTypical EU-wide delivery
- 120,000FFP2 units produced per day
- 14+Countries served across Europe today
- 90%Regionally sourced raw material
We started because most of what was on the market was not a respirator.
MOONLEX was founded in 2020, in the middle of a pandemic, on an uncomfortable observation: a great deal of what was being sold as protection only resembled it. Boxes carried marks that nothing verified. The gap between what a mask claimed and what it filtered was, in many cases, the whole product.
We built a factory in Shtip to close that gap. Everything we make is certified to EN 149:2001+A1:2009 under a European notified body, and every batch is checked before it leaves the building. Production is 80% automated, with a person signing off on quality at every production and packaging stage.
The second thing we refused to accept is that protection has to be uncomfortable. A respirator nobody can stand to wear for six hours is not protecting anybody by hour seven. The MM2-S is built around the people who wear one all day: clinicians, pharmacy staff, production workers, older wearers, and anyone who needs it to simply stay on and stay breathable.
Reliability, compliance, documentation and supply-chain consistency are not optional extras. They are the baseline.
Selected as one of North Macedonia's most outstanding manufacturing and export companies.
In February 2023 the President of North Macedonia, H.E. Stevo Pendarovski, made an official visit to MOONLEX. He toured the production facility, reviewed our European certification standards, and was briefed on our automated processes and our plans for European markets.
An honour, and a standard we have had to keep to since.
Read the official record of the visit
Every claim on this page has a document behind it.
Certification is the product for a procurement team. Ours is not a link to somebody's shared drive. The type examination certificate, the declaration of conformity and the technical data sheet open directly on our certifications page. The notified body's evaluation and product check reports are sent on request. All current, and ready to forward to whoever signs off internally.
- EN 149:2001+A1:2009Filtering half-mask standard. Our MM2-S is classified FFP2 NR.
- CE 2890Notified body CIS INSTITUT, under EU Regulation 2016/425 on PPE.
- EU Module C2Conformity to type with supervised product checks at random intervals.
Current documents cover the 2026 to 2031 certification period. Documents for 2021 to 2026 are available on request.
Manufactured in North Macedonia.
Delivered across Europe.
European production means European logistics. Three offices keep manufacturing, compliance and market access in the same time zone as the people buying from us.
North Macedonia
Sremski Front 1A-26, 2000 Shtip
1,500 m² production site. 80% automated production with human quality control on every batch.
Slovenia
Nove Fužine 33, 1000 Ljubljana
Commercial and compliance base inside the European Union.
Germany
Röntgenstraße 6-9, 67133 Maxdorf
Local representation for German, Austrian and Swiss buyers.
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