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by Quintaernum Unternehmergesellschaft

YOUR SUPPLIER FOR PROTECTIVE EQUIPMENT ACCORDING TO EU 2016/425

Our promise:

  • Warehouse in Germany
  • No advance payment or LoC
  • Shipping within Europe
  • Own production
  • European quality assurance
  • EN 149:2001 +A1:2009
  • EU 2016/425

FFP2-MASKS - RETURN TO EU-CONFORMITY

Companies and politics are currently facing enormous challenges due to SARS-COV 2. Through the interdisciplinary cooperation of experts and lawyers, in the field of legal testing requirements and logistics, we provide companies and political bodies with FFP2 masks in accordance with German and European standards. To this end, we work closely with the largest companies on the global market.

As a state and company authorized body we act as a direct interface between producer and customer. At present we have a warehouse in Germany, as well as exclusive production capacities with certified and repeatedly tested manufacturers on the world market.

Our focus is on the direct supply of breathing masks and personal protection equipment (PPE) in Europe, without transactions to other EU countries. Even for large purchase quantities (>1.000.000 pcs.) the purchase and logistics are carried out and handled in Germany.

Products

Overview of currently available products according to Regulation (EU) 2016/425 and prices can be found here.

Latest regulations

Return to EU-conformity
11.08.2020
In accordance with Section 6 (6) of the Rules of Procedure of the AAMÜ, the following resolution is published:
Based on the findings of the Federal Institute for Drugs and Medical Devices (BfArM) and the Federal Ministry of Labour and Social Affairs (BMAS), there is currently no longer a supply bottleneck for particle-filtering half masks.
This means that a central prerequisite for the exemption possibilities according to § 9 MedBVSV, namely the shortage situation, is no longer given and exemptions in connection with the first-time provision on the EU internal market are no longer permitted.
With the cut-off date of 01.10.2020, economic actors are granted an appropriate transition period.

Decision:
Based on the letter of the BMAS dated 31.07.2020, the deficiency situation necessary for exemption possibilities and decisions according to § 9 paragraph 1 and 2 MedBVSV can no longer be assumed. Therefore, as of October 1, 2020 at the latest, the prerequisites for exemptions according to § 9 (1) and (2) MedBVSV no longer exist.

After the decision and the associated return to EU conformity, dated 11.08.2020, the generally applicable rules and regulations for the import and marketing of PPE/PSA products are again in force in accordance with

  • EN 149:2001 +A1:2009
  • EU 2016/429

You can view these requirements directly with us:

Provider Verification.

Verify if your current supplier complies with the current, applicable guidelines.
The Federal Institute for Occupational Safety and Health maintains a database for this purpose.

Services

With knowledge of key industries, our expertise provides added value to companies looking to expand into China or expand from China to Europe.

Placing on the market & market rollout

Evaluation of the legal requirements for the marketing of goods and products within the Schengen area and domestic market, as well as to and from China

Preparation of legal standards & guidelines

Legal validation and verification for compliance with legal standards and guidelines, according to production and product requirements.

Certification

We assist companies in the certification process, for the introduction of goods into circulation.

Consulting

We have developed a specialization for key sectors, industrial and growth markets, based on several years of experience and advise companies in strategic development.