Summary
- Profile Type
- Business Offer
- POD Reference
- BODE20250715012
- Term of Validity
- 18 July 2025 - 18 July 2026
- Company's Country
- Germany
- Type of partnership
- Commercial agreement
- Outsourcing agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- A German subsidiary of a global healthcare group is seeking an EU-based partner to act as the legal manufacturer/importer for a single-use neutral electrode for electrosurgical applications. The partner should be certified under ISO 13485 and experienced with EU-MDR 2017/745 requirements. A commercial agreement with technical and regulatory responsibility is offered.
- Full Description
-
Cardinal Health Germany Manufacturing GmbH, based in Halberstadt, is a certified manufacturer of adult electrodes, infant electrodes, PSG electrodes and neutral electrodes for electrosurgical applications. As part of Cardinal Health, Inc. (USA), the company operates under strict quality and regulatory frameworks.
The company manufactures a neutral electrode intended for use in electrosurgery. This is a Class IIb single-use device requiring EU-compliant product registration and market entry under the Medical Device Regulation (EU) 2017/745.
Cardinal Health Germany is currently seeking a legal manufacturer or authorized representative based in the EU/EEA who will take over the regulatory responsibility to place the product on the European market. This includes:
• MDR-compliant product registration
• UDI and technical documentation
• Labeling, packaging, and post-market surveillance
• Optional: Distribution of the product in European markets
The partner will benefit from the manufacturing, QA, and product documentation provided by Cardinal Health. A commercial agreement is envisaged. - Advantages and Innovations
-
• Strong compliance foundation: Operations are aligned with EU MDR, ISO 13485, and GMP standards for medical devices.
• Global reach with local expertise: Backed by the global infrastructure of Cardinal Health, while maintaining flexibility and speed through its specialized German facility.
• End-to-end service model: From concept and design to full-scale manufacturing and distribution, all services are provided in-house or via trusted global networks.
• Sustainable manufacturing focus: Ongoing investment in energy-efficient production, recyclable packaging, and process digitization. - Technical Specification or Expertise Sought
-
The partner should have:
• ISO 13485 certification
• Regulatory experience under EU-MDR (ideally for Class I / IIa devices)
• Infrastructure for labeling, vigilance, and documentation
• Optionally: sales or distribution capacity in the EU - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- Goal 9: Industry, Innovation and Infrastructure
- IPR status
- IPR granted
- IPR notes
- Design and manufacturing IP owned by Cardinal Health; branding optional for the partner.
Partner Sought
- Expected Role of a Partner
-
The company seeks long-term partnerships with:
• Pharmaceutical firms, CDMOs, and healthcare technology companies interested in developing or scaling medical products under strict regulatory standards.
• Strategic partners with expertise in device design, regulatory affairs, or sustainable packaging who are interested in co-innovation and access to European manufacturing capacity.
Cardinal Health Germany Manufacturing GmbH sees these partnerships as opportunities to jointly improve healthcare delivery, expand into new therapeutic areas, and reinforce supply chain resilience across the medical sector. - Type and Size of Partner
- SME <=10
- Big company
- SME 11-49
- SME 50 - 249
- Type of partnership
- Commercial agreement
- Outsourcing agreement
Dissemination
- Technology keywords
- 06001005 - Diagnostics, Diagnosis
- 06001021 - Single Use Products and Consumer Goods
- 06001013 - Medical Technology / Biomedical Engineering
- 06001017 - Surgery
- Market keywords
- 05004005 - Diagnostic equipment
- 05004001 - Electromedical and medical equipment
- 05007001 - Disposable products
- Targeted countries
- All countries