Vertically integrated CDMO for medical injection molding and silicone manufacturing, medical tube extrusion, hypotubes, coatings and complete medical devices
Freudenberg Medical
Aachen · Kaiserslautern (DE) · Carrick-on-Shannon · Galway (IE) · Shenzhen (CN) · Yaita (JP) · Carpinteria · Jeffersonville · Minnetonka · Beverly · Baldwin Park (US) · Coyol (CR)New on Amplifa
Vertically integrated CDMO for medical technology and biopharma
Freudenberg Medical is a strategic CDMO partner (Contract Development and Manufacturing Organization) for medical technology and pharmaceutical companies with 12 production sites worldwide in the USA, Europe, Asia and Costa Rica as well as more than 2,700 employees on over 813,000 square feet of production space. The company manufactures medical components and finished medical devices from thermoplastics, medical- and implant-grade silicones, and stainless steel and high-performance alloys – from complex catheters, hypotubes, steerable shafts and handles to precision molding, two-shot and micro molding as well as thermoplastic and silicone extrusion, drug and hydrophilic coatings and solutions for smart medical devices. Manufacturing takes place in ISO Class 7 and 8 cleanrooms with scientifically driven injection molding processes (T.I.M.E.™), automation, in-line inspection and toolmaking. The portfolio also includes single-use assemblies for biopharma, packaging, sterilization management, pad printing and laser marking as well as metrology, testing and validation. Freudenberg Medical is part of the Freudenberg Group, founded in 1849, and supplies more than 70 medical technology OEMs, including 86% of the largest medical device companies.
- Site
- Aachen
- Processes
- Injection molding (thermoplastic), Silicone injection molding / Liquid Injection Molding (LIM), Two-shot / 2K injection molding, Micro injection molding, Insert and over-molding, Compression molding, Thermoplastic extrusion (tubing), Micro-extrusion (HelixMicro™)
- Materials
- PEEK, Pebax (polyether block amide), Polyurethane, Nylon / polyamide, Polycarbonate, PET, Polyolefin, Polyethylene
- Certificates
- ISO 13485:2016, ISO 14001:2015, ISO 45001:2018, ISO 9001:2015, ISO 50001:2018
- Founded
- 2004
- Employees
- 2,700+
- Industries
- Medical technology, Biopharma, Pharmaceuticals, In-vitro diagnostics (IVD), Drug delivery
- 01
Design & Development (Navigate®, DFM, Rapid Prototyping)
- 02
Toolmaking / Tooling Management
- 03
Injection Molding (Thermoplastic, Silicone/LIM, Two-Shot, Micro Molding)
- 04
Extrusion (Thermoplastic, Silicone, Micro-Extrusion)
- 05
Metalworking (Laser Cutting, Grinding, EDM/ECM, Laser Welding)
- 06
Coating (LUBRITEQ™, Drug Coating, Surface Modification)
- 07
Assembly / Device Manufacturing
- 08
Packaging, Sterilization Management, Labeling
- 09
Metrology, Testing, Validation
Manufactured components and products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Injection molding (thermoplastic)Plastics | – | – | 0.05 g – 4 g | High volume (15–350 t presses) | Polyurethane, PEEK, PET, Pebax, Nylon (polyamide), Polyolefin, Polyethylene, Polycarbonate, FEP, PVC, PFA, PVA, ABS, PMMA |
| Silicone injection molding / Liquid Injection Molding (LIM)Plastics | – | – | 0.004 g | – | LSR, HCR, implant-grade silicones |
| Two-shot / 2K injection moldingPlastics | – | – | – | 80 million parts/year | Polycarbonate+TPE, Silicone+thermoplastic, Silicone+silicone, Polypropylene+TPE, TPU (aromatic)+TPU (aliphatic), PCTG+TPE |
| Micro injection moldingPlastics | – | – | 0.004 g (silicone) – 4 g | – | LSR, TPE, PEEK, PSU, PPSU |
| Insert and over-moldingPlastics | – | – | – | – | Thermoplastics, Silicone, Metal inserts |
| Compression moldingPlastics | – | – | – | – | Silicone, HCR |
| Thermoplastic extrusion (tubing)Plastics | ±0.0065 mm | – | – | – | PEEK, Pebax, Polyurethane, Nylon, Polycarbonate |
| Micro-extrusion (HelixMicro™)Plastics | ID from 0.1778 mm, wall thickness from 0.0508 mm | – | – | – | Silicones, Thermoplastics |
| Multi-lumen/co-extrusion, multi-layer and tri-layer tubingPlastics | ±0.015 mm (tri-layer), OD 0.4–4 mm | – | – | – | Pebax, Polyamide, Polyurethane, EFEP, Silicone |
| Braided and coiled tubing extrusionPlastics | – | – | – | – | Thermoplastics, Stainless steel wire, Monofilaments |
| Silicone extrusion (single-/multi-lumen, co-extrusion, braiding)Plastics | – | – | – | – | medical- and implant-grade silicones (platinum-cured) |
| Medical functional coating (hydrophilic, LUBRITEQ™)Surface | – | – | – | 1M+ devices/year | Nylon 6/6.6, Nylon 12, Pebax, Polyurethane, Polypropylene, Silicone |
| Drug coating / drug-device combination productsSurface | – | – | – | – | – |
| Surface modification (plasma treatment, micro-structuring, dip/spray coating)Surface | – | – | – | – | – |
| Laser cutting (metal tubing/hypotubes)Machining | – | – | – | 10 million components/year | Stainless steel, Alloys |
| Centerless grindingMachining | – | – | – | – | Stainless steel, Alloys |
| EDM / ECM (electrical discharge/electrochemical machining)Machining | – | – | – | – | Stainless steel, Alloys |
| Laser weldingJoining | – | – | – | – | Stainless steel, Alloys |
| Precision tip grinding for specialty needlesMachining | – | – | – | – | Stainless steel |
| Electropolishing / passivation / bead blastingSurface | – | – | – | – | Stainless steel, Alloys |
| PTFE coating (proprietary) for hypotubesSurface | – | – | – | – | Stainless steel |
| Laser marking and ablationSurface | – | – | – | – | Metals |
| Pad printing / laser etchingSurface | – | – | – | – | – |
| Medical device manufacturing and finished device assembly (catheters, introducer sheaths, handles)Assembly | – | – | – | – | Thermoplastics, Silicone, Metals |
| Braiding and coiling (metal processing)Joining | – | – | – | – | Stainless steel wire |
| Packaging, sterilization management, labelingAssembly | – | – | – | – | – |
| Product development and design (Navigate®, DFM, rapid prototyping)Engineering | – | – | – | – | – |
| Toolmaking / tooling managementEngineering | – | – | – | – | – |
| Metrology / first-article inspection / gauge R&RTesting | – | – | – | – | – |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Injection molding machines | ARBURG | – | 15–350 t clamping force | – | – |
| Injection molding machines | TOYO | – | 15–350 t clamping force | – | – |
| Injection molding machines | Battenfeld | – | 15–350 t clamping force | – | – |
Additional services
Reference customers
Quality and certifications
Freudenberg Medical manufactures at 12 globally ISO 13485-certified sites in ISO Class 7 and 8 cleanrooms, FDA-registered in the USA, Costa Rica, Germany, Ireland and China. A climate-controlled metrology laboratory, first-article inspection, gauge R&R and the global MasterControl quality management system ensure compliance with FDA, ISO, MDR and MDSAP; in 2024, 15 audits by authorities and notified bodies passed without major findings.
| Evidence | Company |
|---|---|
| ISO 13485:2016 | |
| ISO 14001:2015 | |
| ISO 45001:2018 | |
| ISO 9001:2015 | |
| ISO 50001:2018 |
History
- 1849
Foundation of the Freudenberg Group (tannery, Weinheim) by Carl Johann Freudenberg and Heinrich C. Heintze
- 2004
Start of Freudenberg Medical through the acquisition of Jenline Industries, Gloucester, MA, USA
- 2006
Acquisition of Helix Medical, Carpinteria, CA, USA
- 2008
Acquisition of APEC's thermoplastic injection molding operations
- 2015
Acquisition of Hemoteq (Aachen) – expansion into drug coatings
Yaita site (Japan) added through the acquisition of Fuji Seiko
- 2025
Launch of LUBRITEQ™ (February) and CleanAssure™ (April); awards from Edwards Lifesciences