1 pc
Hygiene pouch
Sealed, shelf-ready
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.
MODEL MM2-S / FFP2 NR / PFE ≥ 94% / EN 149:2001+A1:2009 / CE 2890
CE 2890
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 conformity assessment, the declaration of conformity and the technical data sheet are all here, current, and ready to forward to whoever signs off internally.
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EN 149:2001+A1:2009
Filtering half-mask standard. Our MM2-S is classified FFP2 NR.
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CE 2890
Notified body CIS INSTITUT, under EU Regulation 2016/425 on PPE.
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EU Module C2
Conformity to type with supervised product checks at random intervals.
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ISO 9001 · ISO 14001
Quality and environmental management systems.
Documents are published for both certification periods — 2021–2026 and 2026–2031.
One product. Built to a single standard.
A five-layer filtering half-mask made for people who wear one all day — clinicians, pharmacy staff, production workers, and anyone who cannot afford to fight their own respirator. Certified, documented, and stocked in every European format.
Five layers of protection
5
PP non-woven fabric
Outer shell
4
Water-electret meltblown fabric
Filtration
3
Hot-air cotton or PET non-woven
Comfort core
2
Water-electret meltblown fabric
Filtration
1
PP non-woven fabric
Skin side
Made to stay on for a whole shift.
Fully adjustable nose wire
Moulds precisely to the face, closing the gaps along the bridge of the nose where unfiltered air otherwise gets in.
Soft elastic ear loops
Flex with the shape of the head. Secure without the pressure that makes a mask come off after an hour.
Individually pouched
Each respirator sealed in its own hygiene pouch — shelf-ready, and hygienic to hand out or distribute.
Certified specification
ModelMM2-S
ClassificationFFP2 NR — single use
Filtration (PFE)≥ 94%
StandardEN 149:2001+A1:2009
Notified bodyCE 2890 — CIS INSTITUT
Regulation(EU) 2016/425, Category III
ConstructionFive layers, folded flat
GrapheneGraphene free
Available finishes
White and black are held in stock. Further colourways are produced to order on private label programmes.
Every format, from one pouch to a full truck.
The same certified respirator, packed the way your warehouse actually receives it. Bulk configurations run from the individual hygiene pouch through retail box, master carton and EPAL pallet to a floor-loaded trailer.
10 pcs
Retail box
Consumer-ready, PZN available
1,080 pcs
Master carton
108 retail boxes
21,600 pcs
EPAL pallet
20 master cartons
Your brand. Our factory.
No plant to build, no notified body to negotiate with, no regulatory workload. We manufacture and hold CE conformity for your private label FFP2 respirator; you put your name on it and take it to your market.
200,000
Minimum order to open a private label programme
What you can specify
- Logo and brand name on both pouch and retail box
- Full box design — colour, finish and layout
- Pack sizes of 10, 20 or 50 pieces
- Single-market or multilingual packaging
- Mask colourways beyond the stocked white and black
- Retail-ready or bulk format
CE conformity under your name
We carry the production and the compliance file. You carry the brand.
European lead times
Manufactured in Shtip and shipped overland. No ocean freight, no customs queue.
Documentation your buyers can read
Every test report and declaration issued ready to pass on.
One account manager
The same person from pilot run through to a standing programme.
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.
What that means for an order
72 hours
Stock turnaround when you need it fast
1,080
Respirators in a master carton, the standard trade unit
21,600
Respirators on a standard EPAL pallet
855,360
Respirators in a floor-loaded full truck
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 — 80% automated production, 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.
Production site in Shtip1,500 m²
Automated production, human QC on every batch80%
Regionally sourced raw material90%
Recognised at the highest level.
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.
Shtip · 21 February 2023
Where our respirators are worn.
The same certified MM2-S, specified by very different buyers.
European source, or long-haul import.
The difference procurement teams across Europe are weighing up.
| Criterion | MOONLEX — European | Typical long-haul import |
|---|---|---|
| Delivery into the EU | 3–5 days | 40–80 days |
| Certification | CE 2890, auditable | Frequently unverifiable |
| Material traceability | Traceable at every stage, documented | Limited or unavailable |
| Supply chain exposure | Low — 90% regional sourcing | High — intercontinental dependency |
| Customs and import duty | None within Europe | Applicable, plus admin overhead |
This compares two sourcing models in general terms. It is not a claim about any named competitor.
Climate neutrality was a founding commitment, not a retrofit.
We are working toward a climate-neutral operation, and building production, packaging and sourcing decisions around that goal. These are commitments in progress — we would rather state them plainly than certify them prematurely.
Regional sourcing
Half our raw material comes from North Macedonia and a further 40% from the wider European supply base, cutting intercontinental dependency.
Automated production
Consistent output with human quality control at every production and packaging stage.
Recyclable packaging
We are moving product and shipping materials to fully recyclable packaging, and managing production waste responsibly.
Energy and machinery
We are increasing renewable energy across the factory and offices, and specifying low-consumption machinery as we add capacity.
Renewable energy use and climate neutrality are stated goals in progress rather than certified outcomes, and are described that way deliberately.
Trusted by
Hospitals, pharmacy chains, retail and distribution across Europe.
Sanacorp
Alliance Healthcare
dm
Medi-Markt
Zan Mitrev Clinic
Acibadem Sistina
Lekarna Ljubljana
Diakoneo
Request a quote
Tell us what you need and where it is going. A specialist replies with pricing, lead time and the full documentation set — normally within one business day.
- Volume pricing from pallet quantities upward
- Complete test documentation included with every quote
- Private label available from 200,000 units
- Prices quoted ex-VAT; the rate applied depends on destination
Request received
A MOONLEX specialist will reply to your work email within one business day with pricing and documentation.