Medical Components

Components for medical bags (urine, infusion, nutrition), drainage systems, urology and immobilisation equipment, identification bracelets, diagnostics, and surgical devices. Most are injection moulded in 1K, 2K, or 3K configurations; many move through downstream assembly, inspection, printing, and packaging at the same Danish site under one ISO 13485 quality management system. Beyond the standard catalogue, Carmo also develops OEM-specific variants and fully custom-designed components.

Yes. Carmo manufactures injection-moulded medical sampling ports used in catheters (urinary catheter systems especially), drainage assemblies, and tubing connector lines — designed for sterile fluid sampling without breaking the closed system. Variants include catheter sampling ports, sample port connectors, and needle-free sampling ports. Manufactured under Carmo's ISO 13485 quality management system. Carmo supplies the component; MDR legal-manufacturer responsibility rests with you as the OEM placing the finished device on the market.

A wide span of medical-grade thermoplastics, including proprietary Carmo PVC recipes refined over decades. Multi-material 2K and 3K constructions enable one-piece designs that eliminate separate assembly and adhesive failure modes — fewer steps, fewer leak paths, fewer regulated-process variables in your device file. Material selection is part of the integrated design and development engagement.

Yes — and longer than most. Carmo has run a certified quality management system since 1993, and certified to ISO 13485 since 2013:

Design and development sit inside that certified scope, not adjacent to it. Carmo is a component supplier; MDR legal-manufacturer responsibility rests with you as the OEM placing the finished device on the market.

Yes. Injection moulding for medical components takes place in production cells classified as ISO Class 8 clean zones per ISO 14644-1:2015, operating under the ISO 13485 QMS. Downstream assembly, inspection, printing, and packaging move into two fully validated ISO Class 8 cleanrooms at the same Danish site. Routine internal particle-count monitoring (0.5 / 1.0 / 5.0 µm bands) is complemented by recurring external verification by a specialist; the 2018 site expansion added 200m² of additional ISO Class 8 cleanroom capacity.

Yes. Assembly, inspection, printing, and packaging of medical components are all carried out in the validated ISO Class 8 cleanrooms at the same Danish site as moulding, all under the ISO 13485 QMS. Component-level traceability documentation accompanies cleanroom-produced parts — batch records, in-process controls, material-lot traceability — in a documentation set sized for medical-OEM supplier qualification and customer audit.

Yes. Beyond the standard catalogue, Carmo develops OEM-specific variants and fully custom-designed components from concept through volume. The integrated design, tooling, moulding, and cleanroom-assembly teams handle the full lifecycle without supplier handovers — which simplifies your regulated documentation and shortens validation cycles. New designs typically start with Carmo Print Moulding for iteration in production material (see /en/services/rapid-prototyping/) and transition into definitive tooling for volume.

Your project doesn't change hands between prototype and volume. The same Danish site and the same engineering team carry your project from Carmo Print Moulding iteration through validation builds and into regulated volume production. Carmo Print Moulding sits outside the certified ISO 13485 scope (rapid-iteration prototyping runs on case-by-case engineering documentation); validation builds and volume production engage the certified QMS. Your supplier qualification, audit trail, and documentation extend rather than restart at that boundary — removing the cost of re-qualification, audit, and renegotiation that customers face when moving between separate prototype and production suppliers.

Yes. Carmo's certified ISO 13485 scope reads verbatim: "" Design and development are inside that certified scope, not adjacent to it. Supplier-qualification documents, on-site audits, and questionnaires are part of the routine engagement model from the design phase onward, served from the same QMS records that govern volume production. The QMS has been continuously certified since 2013.

Patented product family of two one-piece 2K-moulded valves for medical bags — a Cross Valve and a Turnvalve — engineered to replace multi-component assembled valves. One piece instead of an assembly: fewer parts, fewer failure points, lower component cost, less material per device, lower CO₂ footprint. Both variants are pre-launch — pilot engagements with selected medical-bag OEMs scoped on request.

With Carmo you get a supplier who is there as long as your device is in the market. Twenty to thirty year relationships are common — medical OEMs have run the same Carmo components on the same medical device for the regulated life of the device, including through validation cycles, regulatory pathway updates, and material transitions. Privately held and Danish-owned since 1941, single integrated site, three owners across 85 years of continuous independent operation — the relationship is engineered to outlast your validation cycle, and the structural continuity is the reason it can.

Yes — and the hybrid model is what gives Carmo lifecycle insight no contract-manufacturer pureplay can build. Because Carmo also develops and lives with its own component portfolio over decades, the team has first-hand experience of the full lifecycle cost of design choices: material changes (REACH, RoHS, DEHP phase-outs), copy tooling at end-of-life, re-validation triggers, regulatory pathway updates, the practical realities of sustaining a medical-device component over its registered life. You're not paying for overhead — you're benefiting from depth a pure contract manufacturer cannot offer. Customer projects run under the same QMS, the same engineering team, the same priority model; Carmo's own product work sits in the same queue, not ahead of it.

A component-level CO₂ calculator runs directly in Carmo's ERP and produces per-component emissions data you can include in your Scope 3 reporting. The mechanism makes per-component carbon intensity visible at the granularity OEMs need to support their own sustainability disclosures — actual numbers for your specific component runs, not segment-level averages. Carmo is among the first Danish plastics SMEs committed to the Science Based Targets initiative (SBTi certificate 40001785), targeting a 50% reduction in scope 1 and 2 emissions by 2030 aligned with the Paris Agreement 1.5°C target.

Engage at the concept or design stage to get the full benefit of design-for-manufacturability, material selection, and rapid prototyping in production material before tooling investments are committed. Contact [email protected] or visit carmo.dk; a brief mutual NDA covers the scoping discussion (turnaround days, not weeks), with a project-specific agreement settled before development work begins. If your project is on a tight timeline and your component need matches Carmo's standard catalogue — HF-weldable eyelets, valves, threaded nozzles, filler flanges, snap grommets, drainage fittings — the fastest path is to start from the catalogue: proven designs available from stock, produced under the same ISO 13485 QMS as custom work.