Our Mission Statement

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Contact Us

  • 1-779-333-67992
  • info@industrybusiness.com
  • 3042 Rotterdam, Netherlands; Van Noortwijcksingel
Address: Poznańska 132 St.
62-052 Komorniki, Poland
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Certificates

Our company - ABA Sp. z o.o. - has been delivering high-quality plastic packaging for the pharmaceutical industry and related sectors for years. We place enormous emphasis on quality, safety and compliance with legal requirements. This is confirmed by numerous certificates we have obtained and quality systems implemented in our organization.

Quality Policy

Quality policy is based on continuous process improvement, meeting customer requirements and legal regulations, as well as caring for the safety and reliability of our products.

ISO 9001:2015

Design and production of closures, medical devices and auxiliary products for the pharmaceutical industry and other industrial sectors.

EC Certificate No. 1434-MDD-165/2021
(Directive 93/42/EEC)

Certificate of compliance with Directive 93/42/EEC concerning medical devices. Covers the quality assurance system for manufacturing and final inspection of medicine dispensers with measuring scale.

Annex to PCBC Certificate – List of Medical Devices

Document constitutes an annex to EC certificate No. 1434-MDD-165/2021 and contains a list of medical devices covered by certification, such as: spoons, cups and measuring devices for medicine administration with various capacities. The certificate confirms product compliance with applicable EU standards.

PCBC Declaration – EC Certificate Validity

Polish Centre for Testing and Certification S.A. confirms that EC certificate No. 1434-MDD-165/2021 for medicine dispensers with measuring function by P.P.H. ABA Sp. z o.o., remains valid and is under surveillance in accordance with applicable EU regulations concerning medical devices.

ISO 8317

Standard concerning child-resistant packaging. Our 18 mm diameter caps meet the requirements of this standard, which confirms their safety for use in pharmaceutical packaging applications.

ISO 8317

International standard concerning child-resistant packaging. Our 28 mm diameter caps that we offer have been tested and fully comply with the requirements of this standard. They provide a safe solution for use in pharmaceutical and chemical product packaging, where restricting access for children is crucial while maintaining ease of use for adults.

ISO 13485 – System Implemented

Our company has implemented a quality management system compliant with ISO 13485 standard, which is specifically designed for medical device manufacturers. We are currently at the stage of preparing for full certification.

Copyright 2024 P.P.H. ABA Sp. z o.o. Wszelkie prawa zastrzeżone. | Polityka Prywatności | Regulamin

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