Freudenberg Medical

What Freudenberg Medical does

Freudenberg Medical is a global contract design and manufacturing organization (CDMO) serving medical device and biopharmaceutical companies. Founded in 2004 and headquartered in Beverly, Massachusetts, the company operates as a wholly-owned subsidiary of Freudenberg Group, the German family-owned industrial conglomerate founded in 1849. The company serves eight primary verticals: biopharma (tubing, connectors, single-use systems for bioprocessing), cardiac and interventional (electrophysiology, vascular, neurology, structural heart), drug delivery, ENT, endoscopy, in-vitro diagnostics, ophthalmology, and smart medical devices. Notable footprint includes manufacturing catheter solutions supporting one in every four electrophysiology (EP) ablation procedures worldwide and over 16 million complex catheters shipped annually from its Irish operations alone.

The company's technical capabilities span the full device value chain through seven technology platforms: custom extrusions (thermoplastic and silicone), custom molding (including liquid injection molding, micro molding, two-component, and insert molding), device manufacturing and catheter assembly, precision metals (hypotubes, specialty needles, steerable components), and coatings. Proprietary technologies include LUBRITEQ, a UV-curable single-step hydrophilic coating backed by 25+ years of coating science and 40+ coating scientists globally, Hemoteq drug-coating technologies for drug-eluting stents and drug-coated balloons, and the T.I.M.E. (Thermoplastic Injection Molding Excellence) methodology. Manufacturing spans 12 sites and 813,000+ square feet across the United States (Beverly, Carpinteria, Baldwin Park, Jeffersonville, Minnetonka), Germany (Kaiserslautern, Aachen), Ireland (Carrick-on-Shannon, Galway), Costa Rica (Coyol), China (Shenzhen), and Japan (Yaita), with quality systems certified to ISO 13485, ISO 14001, ISO 45001, ISO 50001, MDR, MDSAP, and FDA GMP/QSR standards.

Freudenberg Medical operates a direct enterprise sales model with global account management and field sales teams engaging medical device OEMs and biopharma manufacturers from concept through commercialization. Revenue is generated through contract manufacturing services, component and device unit sales, and a differentiated no-royalties, no-fixed-fee commercial model for LUBRITEQ coatings designed to reduce product launch risk. The company leverages a multi-channel marketing approach anchored in industry tradeshows (MD&M West, Medtec China, CPHI Milan, COMPAMED, etc.), digital content, and thought leadership. Customer relationships are long-term and project-based, exemplified by three consecutive Edwards Lifesciences Supplier Excellence Awards (2023-2025). Ownership by Freudenberg Group provides long-term capital stability with no venture capital or private equity backing.

Name

Freudenberg Medical

Legal name

Freudenberg Medical LLC

Website

https://freudenbergmedical.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Freudenberg Medical is a global CDMO providing vertically integrated contract design and manufacturing for medical device and biopharma companies, specializing in catheters, minimally invasive devices, precision molding, extrusions, hypotubes, and proprietary drug and hydrophilic coatings across 12 manufacturing sites.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing (CDMO)

NAICS

Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Medical device contract manufacturing
• Minimally invasive devices
• Hydrophilic coatings
• Catheter manufacturing
• Biopharma single-use assemblies

Headquarters

HQ city

Carpinteria

HQ country

United States

HQ region

North America

Offices12 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Supply Chain, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Contract Manufacturing Services: Freudenberg Medical generates revenue through contract design and manufacturing services for medical devices and biopharma applications. This includes custom extrusion, precision molding, device assembly, metals components, and coating services. Revenue is project-based with long-term customer relationships spanning product development through volume production.
2. Component and Device Manufacturing: Manufacturing and sale of medical components (tubing, catheters, molded parts) and finished devices. Revenue derived from unit pricing for manufactured products with volume-based pricing.
3. Coating Services and Solutions: Hydrophilic and drug coating application services with no-royalties, no-fixed-fee commercial model for LUBRITEQ products.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels7 records

Core offering

Freudenberg Medical is a global contract design and manufacturing organization (CDMO) that develops and manufactures specialty medical device components and minimally invasive device solutions for medical device and biopharmaceutical OEMs. Its offering spans custom extrusions, custom molding, device assembly, precision metals (hypotubes and needles), and proprietary drug and hydrophilic coatings, supported by design, program management, automation, and regulatory services from concept through series manufacturing across 12 manufacturing sites in the Americas, Europe, and Asia.

Product overview

Freudenberg Medical is a contract design and manufacturing organization (CDMO) providing vertically integrated capabilities across the medical device and biopharma value chain. The company operates as a single unified platform offering custom extrusion, custom molding (thermoplastic and silicone), device manufacturing/catheter assembly, metals (hypotubes), and coatings (drug and hydrophilic). Key products include LUBRITEQ (hydrophilic coating), CleanAssure (sterile single-use assembly cleanroom service), and Hemoteq drug coatings. The company combines clinical acumen with deep materials expertise supporting customers from ideation and design through development and series manufacturing, with 12 global manufacturing sites across the Americas, Asia, and Europe.

Differentiator

Problem solved

Functional benefit

Brands

• LUBRITEQ™: UV-curable, single-step hydrophilic coating solution for medical devices with over 25 years of coating science expertise
• T.I.M.E.™
• CleanAssure™

Products and services

• LUBRITEQ Hydrophilic Coating UV-curable, single-step hydrophilic coating solution for medical devices that combines advanced surface chemistry with Freudenberg Medical's in-house device design and manufacturing capabilities; backed by over 25 years of coating science expertise and offered under a no-royalties, no-fixed-fee commercial model. Targeted at medical device OEMs needing validated hydrophilic coatings for catheters and minimally invasive devices.
• CleanAssure Controlled Cleanroom Service ISO Class 5 controlled cleanroom service integrated with gamma sterilization for producing clean and sterile single-use assemblies for biopharmaceutical manufacturers. Reduces contamination risk, eliminates customer cleaning validation burden, and minimizes production downtime.
• Hemoteq Drug Coatings Proprietary drug-coating solutions for drug-eluting stents and drug-coated balloons, now operating under the Freudenberg Medical brand following the January 2026 transition from Hemoteq AG. Targeted at combination product OEMs in drug delivery.
• Custom Extrusions Custom extrusion services providing tight tolerances, complex geometries, and material performance for medical and biopharma applications, including thermoplastic and silicone tubing.
• Custom Molding Precision thermoplastic and silicone molded components and devices for medical and biopharma applications, including liquid injection molding (LIM), two-component molding, micro molding, and insert molding.
• Device Manufacturing High-volume sub- and finished device assembly of catheters, implantable, and smart devices across vertically integrated manufacturing sites.
• Metals (Hypotubes and Engineered Needles) Expertise in hypotubes, precision metal tubing, steerable components, and engineered needles for minimally invasive medical devices, including manufacturing from the Fuji Seiko facility in Yaita, Japan.
• Coatings (Drug and Hydrophilic) Drug and hydrophilic coatings for targeted drug delivery and enhanced performance of medical devices, including controlled drug delivery coatings, drug-coated balloons, and drug-eluting stents.

Quantifiable outcome

• Over 16 million complex catheters shipped annually from Irish operations
• +3 more outcomes

Named customers2 records

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Four partnerships are on record, tiered core and support.

• Fuji SeikocoreStrategic or Co-development Partner · 10 November 2025Acquired Fuji Seiko in Yaita, Japan in November 2025 to strengthen Freudenberg Medical's metals business and global hypotube supply chain. The acquisition enhances precision tubing capabilities and extends the company's precision metal manufacturing footprint in Asia.
• CINDE (Coalición Costarricense de Iniciativas de Desarrollo)supportStrategic or Co-development PartnerCINDE is Costa Rica's investment promotion agency supporting foreign companies. They collaborated with Freudenberg Medical on the Costa Rica expansion, providing support for the $25 million second facility investment and workforce development.
• David Schnur AssociatescoreStrategic or Co-development PartnerExclusive multi-year strategic agreement where David Schnur Associates (DSA) partners with Freudenberg Medical to deliver precision metals and coating solutions. DSA provides specialized sales and technical support for metal components.
• Hemoteq AGcoreStrategic or Co-development PartnerHemoteq became a joint venture partner in 2015 and was fully acquired by Freudenberg Group in 2025. Transitioned to Freudenberg Medical Hemoteq GmbH in January 2026 as part of 'One Freudenberg Medical' brand integration. Provides drug coatings and hydrophilic coating technologies.

Scale indicators11 records

Recent moves12 records

Expansion highlights6 records

Direct peers

• Integer Holdings: Largest pure-play medical device CDMO with comparable vertically integrated capabilities in components, leads, and finished devices for cardiac, vascular, and neuromodulation customers. Directly competes with Freudenberg Medical for catheter and interventional device programs.
• Nordson Medical: Division of Nordson Corporation offering medical tubing, fluid components, and precision assembly for OEMs. Competes directly in catheter extrusion, balloon manufacturing, and minimally invasive device subassemblies.
• Spectrum Plastics Group: Specialty medical plastics CDMO with extrusion, molding, balloon forming, and catheter assembly capabilities serving similar minimally invasive device OEMs. Recently combined with Aptyx; directly comparable business model and technology stack to Freudenberg Medical.
• Confluent Medical Technologies: Nitinol and polymer medical device CDMO specializing in catheters, balloons, and braided/reinforced shafts for interventional OEMs. Competes with Freudenberg Medical in hypotubes, specialty coatings, and finished catheter assemblies.
• Heraeus Medical Components: Division of Heraeus Group providing medical components, hypotubes, and coatings including drug coatings for combination products. Competes with Freudenberg Medical in metals, drug-eluting coatings, and contract manufacturing services.
• Endeavor Industries: Medical device contract manufacturer focused on nitinol, polymer extrusions, and minimally invasive catheters. Direct competitor for interventional catheter OEMs.
• J-Pac Medical: Medical device CDMO providing finished device assembly, packaging, and sterilization for OEMs, with strong presence in biomaterials and suture-based products. Comparable in offering integrated contract manufacturing plus sterilization services (CleanAssure-adjacent).
• Flexan: Medical device CDMO focused on precision silicone and rubber molding, extrusions, and finished device assembly. Closely overlaps with Freudenberg Medical's silicone molding expertise in Carpinteria and Kaiserslautern.

Broad incumbents

• Teleflex Medical OEM: Diversified medical device manufacturer with an OEM division offering extrusions, catheters, and finished device manufacturing. Broader portfolio than Freudenberg Medical but overlapping in custom extrusions and interventional components.

Regional players

• Donatelle Plastics: US Midwest-based medical device contract manufacturer specializing in injection molding, assembly, and silicone parts. Comparable core capabilities but smaller scale and US-centric footprint versus Freudenberg Medical's global presence.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@freudenbergmedical
• LinkedInlinkedin.com/company/freudenberg-medical
• Xx.com/freudenbergmed

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Freudenberg Medical