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CE-FFP3

CE-FFP3
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CE-FFP3

Product catalog summary
Conformity Certificate Overview:
This document is a conformity certificate for a particle filtering half mask, Model LH-3 (class FFP3 NR), issued to Zhejiang Lanhine Medical Products Ltd. It covers the period from March 3, 2021, to March 2, 2022, under Regulation (EU) 2016/425 on personal protective equipment (PPE), Annex VII.
Key Specifications and Standards:
  • The product complies with harmonised standards PN-EN 149+A1:2010 and EN 149:2001+A1:2009.
  • The mask is intended for single-use only.
Assessment and Testing:
  • Annual assessments confirmed compliance with the specified standards and type-examined product.
  • Sample selection and testing were conducted, showing positive results.
  • Production was assessed as homogeneous with no non-conformities found.
Notified Body and Certification Details:
  • The notified body involved is Polski Rejestr Statków S.A., with the notified body number 1463.
  • The EU type examination contract number is 113/2021, dated January 29, 2021.
Conclusion:
  • The personal protective equipment is compatible with the type defined in the EC type-examination certificate.
  • The overall assessment of the annual surveillance was positive.
Attachments:
  • Visit report No. CW/MoK/PPER/83/2021 dated March 3, 2021.
  • Test report No. CL/PCLB8/7/3/2021 issued by PRS S.A. Testing Laboratory on March 3, 2021.
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Catalog excerpts

CE-FFP3-3

CERTYFIKAT ZGODNOŚCI Z TYPEM W OPARCIU O WEWNĘTRZNĄ KONTROLĘ PRODUKCJI ORAZ NADZOROWANE KONTROLE PRODUKTU W LOSOWYCH ODSTĘPACH CZASU (Moduł C2) CONFORMITY TO TYPE CERTIFICATE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS (Module C2) Nr No. Okres objęty certyfikatem Period covered by the certificate Dokumenty odniesienia: General reference documents: Posiadacz certyfikatu Certificate holder Rozporządzenie UE 2016/425 dotyczące środków ochrony indywidualnej (PPE), załacznik VII Regulation (EU) 2016/425 on personal protective equipment (PPE), Annex VII Zhejiang...

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CE-FFP3-4

Roczna ocena niejednorodności produkcji Annual assessment of production non-homogeneity Zastosowana metoda przy dokonaniu oceny Method employed to perform assessment Inspekcja procesu produkcyjnego i zapisów z prób On-site review of production and test records Audit kontroli procesu produkcyjnego On-site audit of production control Ocena niejednorodności produkcji poprzez ocenę jednej dużej próbki Production non-homogeneity assessed by selection of a single, large sample Ocena niejednorodności produkcji poprzez ocenę próbek w ciągu roku Production non-homogeneity assessed by assessment of samples...

 Open the catalog to page 4

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