Our company has recently renewed the FFP2 B-Certificate. This renewal once again confirms that our products meet the strict requirements for entering the European Union market.
Compliance Framework in the European Market
To legally supply FFP2 masks in the EU, manufacturers must comply with the CE conformity assessment process. This includes:
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CE Marking – The EU’s conformity mark for safety, health, and environmental protection.
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B Certificate (EU Type Examination Certificate) – Independent testing by a Notified Body to verify that the mask design meets EN 149:2001 + A1:2009 standards, covering filtration efficiency, breathability, and leakage.
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D Certificate (Production Quality Assurance) – Certification of the factory’s quality system, ensuring that each production batch maintains consistent quality.
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Continuous Compliance – Maintaining up-to-date technical documentation, risk assessments, and test records for regulatory inspection.
B and D Certificates: Complementary Roles
Both certificates play different but complementary roles in the compliance process:
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B Certificate confirms that the product design complies with EU standards.
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D Certificate ensures that production continues to comply with the same standards over time.
Together, they form the foundation of legal and sustainable access to the European market.
Our Commitment
The renewal of the FFP2 B-Certificate reflects our company’s long-term commitment to product quality, regulatory compliance, and global responsibility. We will continue to:
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Deliver safe and reliable protective products to our partners
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Ensure consistent compliance with European standards
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Strengthen trust with healthcare providers, distributors, and end users
Compliance is not only a regulatory requirement but also a responsibility.
We remain dedicated to providing trusted, certified, and high-quality protective solutions to the European market.
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Post time: Sep-15-2025