We have successfully renewed our FFP2 certification under Module B (EU Type Examination) and Module D (Production Quality Assurance). This combination is the recognized route for high-risk PPE in the EU and gives buyers confidence that both the design and the ongoing production meet regulatory requirements. If you need documentation, onboarding for new models, or tender support, just reach out—we’re ready to help.
What is FFP2 Certification?
FFP2 respirators are assessed against the EN 149 standard under the EU PPE Regulation. In plain terms, certification checks that the product design is safe and effective, and that mass production consistently matches that approved design.
What Module B Covers (Design Approval)
Module B is a one-time approval of the product design. A notified body reviews technical documents and samples to confirm the design meets applicable safety and performance requirements.
What this means for you: our approved models have a verified, compliant design foundation.
What Module D Covers (Ongoing Quality Assurance)
Module D audits our manufacturing and quality system to ensure every production run stays aligned with the approved design. It includes regular surveillance by the notified body.
What this means for you: continuous, controlled production with documented processes, traceability, and stable quality.
Why B + D Matters to Buyers and Partners
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Trust at scale: proven design plus audited production, not just one-off tests.
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Smoother compliance checks: complete paperwork for importers, distributors, and tenders.
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Consistency: quality controls, supplier management, and traceability built into daily operations.
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Faster onboarding: easier to add or update models within an established, audited system.
What We Provide
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Current certificates: renewed Module B and Module D for FFP2.
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Documentation pack: Declaration of Conformity (DoC), label/packaging drafts, and certificate copies for your files.
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Model onboarding: guidance to add new SKUs under the approved scope.
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Tender & audit support: quick responses to buyer questionnaires and compliance checks.
Product Marking (At a Glance)
Our FFP2 products are supplied with clear, standards-based labelling (e.g., model name, FFP2 class, CE mark with the notified body number) and a user instruction sheet. If needed, we can align artwork with your private-label or market requirements.
Work With Us
Our Module B + D certificates are up to date, and our team is set up for rapid coordination—from samples and paperwork to ongoing supply.
Send us your requirements, and we’ll provide the right documents and a straightforward plan to move ahead.
Post time: Oct-29-2025