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Expanded manufacturing capabilities at A. Hopf. To further strengthen its manufacturing capabilities for medical plastic components, A. Hopf, part of the Promepla Group, has commissioned a new two-component (2K) injection moulding machine. Two-component injection moulding enables the combination of two thermoplastic materials or colours within a single, fully integrated moulding process. This technology is particularly suitable for medical component applications requiri

At Medical Tubing, we specialise in the design and extrusion of medical-grade twin tubes. A key advantage of our twin tubes lies in the precise control of bonding strength between the two tubes. This strength can be adjusted to meet specific design requirements, ensuring consistent quality and reliable performance. Our twin tubes can be fully customised with a wide range of options: Various diameters, Shore hardness levels, colors, and surface finishes Colored stripe fo

Secure sealing solutions for minimally invasive procedures Promepla’s Tuohy Borst Adapters are designed to provide a reliable, leak-proof seal during catheter or fiber insertion in minimally invasive procedures. Manufactured entirely in-house – from mould design to injection moulding and assembly – these single-use adapters ensure high quality and full traceability. Made of polycarbonate with a thermoplastic elastomer seal, Promepla’s Tuohy Borst Adapters allow smooth

Reliable performance for demanding medical applications. At A. Hopf, we design and manufacture high-performance medical stopcocks trusted by device manufacturers across Europe. To evaluate their performance, we conducted internal comparative tests* with four widely used stopcocks available on the market. Key results (under defined test conditions): The flow rate of our stopcocks is on average 15% to 36% higher, including in comparison with products marketed as “high flow.

Medical Tubing also extrudes PVC-free tubing. At Medical Tubing, we offer the extrusion of PVC-free medical tubes, made from materials such as EVA, PE, PP, and many different TPEs like SEBS. These alternatives to PVC provide a wide range of technical possibilities, including various Shore hardness levels and surface finishes (transparency, flexibility, tactile feel, etc.). Some of these materials also offer particularly interesting functional properties: For example, some

Promepla participated in CPC University this fall. At Promepla, our mission is to provide innovative and reliable solutions to the medical device industry – both through custom design and manufacturing and through a comprehensive selection of high-quality standard components available in our online catalog. As part of this commitment, we are proud to be one of the few exclusive distributors of CPC (Colder Products Company) components in Europe. A trusted partner in fluid

This appointment is marking a significant milestone in the company’s long-term growth strategy and is strengthening its leadership. Michel Sasportes, President and Chairman and Marc Danchin, Administrator of Promepla, commented: “It is a decision we have carefully considered, reflecting our desire to provide Promepla with a clear long-term vision while continuing the Group’s development.” Jacques-Henry Grislain brings extensive experience in the biotech and healthcare sec

Promepla is a new member of the Collège Français de Métrologie (CFM). The CFM is a reference in the field of metrology for all those involved in measurement, helping its network members to optimise their practices. Why did we decide to join the CFM? Our mission is to design and develop components and assemblies for medical devices on behalf of our customers. We aim to constantly innovate using new techniques, adding value to the product, both in terms of its compositi

We are pleased to present our new company websites: A. Hopf Medical Tubing Members of the Promepla group since 2022 and 2023, our two companies now have two dedicated websites. The products manufactured by each of them are presented and the content also reflects their values and expertise, with a design in line with the Promepla brand image. Feel free to browse them to get to know us better.

Promepla S.A.M. has received its CE marking certificate for almost 90 of its products under Regulation (EU) 2017/745 on medical devices (MDR). The certificate, issued by the Italian notified body IMQ S.p.A (0051), covers class Is (sterile) and class IIa devices, divided into 5 families: ophthalmology dental infusion general surgery general surgery smoke evacuation. This CE mark confirms Promepla’s position as a leading player in the field of medical devices. As a reminder, me

We are pleased to introduce a new section in our components catalog, the A. Hopf dedicated section. These injection molded parts are manufactured exclusively in Germany and include: EnFit adaptors and rings Caps Stopcocks Straps Clamps Chambers & covers Y fittings Please contact us if you would like to get more information about these components: contact@promepla.com About A. Hopf GmbH A. Hopf Kunststoffverarbeitung GmbH is a high-precision injection molder and mold manufactu

The PVC used in these new flexible medical hoses is manufactured using: Ethylene derived from Used Cooking Oil (UCO); these wastes and residues of biological origin do not compete with the food chain, therefore this PVC is a bio-circular PVC. Chlorine produced with renewable electricity; wind or solar energy is used for the chlorine electrolysis process, making this PVC a renewable energy-derived PVC. Consequently, the carbon footprint of this PVC is significantly lower than

The DOTE substance (2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4- stannatetradecanoate), a thermal stabilizer commonly used in rigid PVC, was added in 2022 to Annex XIV of the European Union (EU) REACH Authorisation List due to its “toxic for reproduction” intrinsic property (Article 57c). As a result, DOTE should no longer be used in medical device components from May 1st 2025. Do any of your PVC products still contain DOTE? We are at your disposal to help you

A. Hopf GmbH, a pioneer in the development of BPA-free components, now features a PVC-free IV set. This set consists of: A drip chamber, made of polypropylene (PP), a cost-effective alternative to PVC. A PVC-free tube, made of ethylene-vinyl acetate (EVA) for the inner layer, and of styrene-ethylene-butylene-styrene (SEBS) for the outer layer. Regarding the various connections (since PP can be difficult to bond and requires special treatment): The drip chamber provides a clam

Renewal of our ISO 13485 certification for medical devices We are happy to announce that we have renewed our ISO 13485:2016 certification for 3 years. This is the result of the hard work and daily commitment of our teams. To review our certificate and find out more about our quality assurance and regulatory affairs department.

We are expanding our range of services and industrial capabilities with the acquisition of the French company Medical Tubing. Based in Le Bousquet d’Orb, in the Hérault region, Medical Tubing offers its customers 30 years of experience in thermoplastic extrusion. The company serves all medical markets with tubes of all sizes, multi-layer and multi-lumen. It also offers compounding of multiple resins for greater responsiveness. With Medical Tubing, we complete our offering as

We are proud to announce the acquisition of A. Hopf Kunststoffverarbeitung GmbH, a family-owned German company based in Cadolzburg, specialising in plastic injection moulding for the life sciences sector. Founded in 1949 by Mr Anton Hopf, A. Hopf GmbH was one of the pioneers of injection moulding in Germany. Since then, the family name has been associated with high quality and customised solutions for single-use life science components. With a 1600 sqm production area, 350 sq

For our innovative client, we have reviewed and analyzed decompression devices on the market and redefined the market standard with new design and improved performance for end users. DEVELOPMENT PROCESS → PROJECT CAD Design Design for Manufacture Mold Manufacturing Assembling Tools Manufacturing FMEA Risk Analysis → OUTCOME Design History File IQ OQ PQ Validation Plan CE Mark → MANUFACTURING Injection Molding Over-molding Tip forming Driling Pad Printing Assembling; Packagi

After industrialization of an initial version of the device, our R&D team has fully redesigned the new version based on competitive review of functionalities. In addition, we have co-developed and co-patented part of the product. DEVELOPMENT PROCESS → PROJECT Concept Pre-study CAD Design Rapid Prototyping Material Selection Design for Manufacture Mold Manufacturing Assembling Tools Manufacturing FMEA Risk Analysis → OUTCOME Design History File IQ OQ PQ Validation Plan CE Mar

Our client, Physio-Assist has developed an innovative concept of equipment and tubing set dedicated to bronchial pathologies. We have acted as their product development and industrialization partner and have help drive the concept to fully operational equipment. Physio-Assist: A French innovative company search a partner for equipment and disposable device development. DEVELOPMENT PROCESS → EQUIPMENT PROJECT Design for Manufacture Mold Manufacturing FMEA Risk Analysis → DIS