Development and distribution of orthopedic aids, shoes, insole systems and implants for foot surgery
DARCO (Europe) GmbH
Raisting (headquarters, production, European distribution center) · Huntington, WV (DARCO International, Inc., USA) · Halesworth, Suffolk (DARCO UK) · Dharwad, Karnataka (DARCO Medical India) ·New on Amplifa
About DARCO
DARCO (Europe) GmbH, headquartered in Raisting (Upper Bavaria), is the European distribution center of the DARCO International group, a manufacturer specializing in orthopedic aids and shoes since 1985. The portfolio includes postoperative dressing, offloading and cast shoes, orthoses and bandages, pressure-relieving positioning aids, pre-cut tapes, modular insole systems for diabetes and wound care, as well as accessories and child-appropriate products; since 1992 DARCO has also been developing its own implants and osteosynthesis products for foot surgery, which have been produced in-house since 2005. Development takes place in-house, among other things with 3D printing; the production of osteosynthesis products is located at the Raisting site, with further production and distribution in the USA, Great Britain, India and China. The materials processed are mainly plastics such as EVA, PE and PU foams, Poron®, Plastazote®, neoprene and polyester as well as textile and dressing materials. Customers are foot surgeons, clinics, specialist retailers and care services; the products are used in 53 countries and, through the Society for Foot and Ankle Surgery e. V. (GFFC), the company is closely connected with the professional community. Production takes place as a medical device manufacturer (Class I) under certified quality management in accordance with DIN EN ISO 13485.
- Site
- Raisting
- Processes
- Design and development of orthopedic aids, Manufacture of orthopedic aids (medical devices Class I), In-house production of osteosynthesis products (foot surgery implants), Product development / R&D, In-house production (osteosynthesis products, China), Training and further education, MDR compliance / declarations of conformity
- Materials
- EVA foam, PU (polyurethane, soft), PE foam, Poron®, Plastazote®, Layered foam, Neoprene, Polyester (stretch in both lengthwise and crosswise directions)
- Certificates
- ISO 13485, ISO 14001:2015, ISO 9001, ISO 14001, MDR compliance (CE, UDI)
- Founded
- 1985
- Industries
- Medical technology / medical devices, Orthopedic aids, Foot surgery, Diabetes and wound care, Nursing care
- 01
Product development / R&D (including 3D printing)
- 02
In-house production (osteosynthesis products, manufacturing in China)
- 03
Quality management in accordance with ISO 13485
- 04
MDR compliance / declarations of conformity
- 05
Assembly and finishing of the aids
- 06
Distribution in Europe, USA, UK, India, China
- 07
Training and further education
Materials and Processes
EVA foam
Foam with different Shore hardnesses for modular insoles such as the Puzzle Insole®.
PU (polyurethane, soft)
Machinable material with high resilience for cushioned comfort insoles.
PE foam
18 mm core layer of the PegAssist® honeycomb insole for pressure redistribution.
Poron®
Shock-absorbing foam used in combination with PE and EVA in insoles.
Plastazote®
Foam material for WCS insoles.
Neoprene
Elastic material for accessories such as toe protection.
Polyester (stretch in both lengthwise and crosswise directions)
Soft insole cover of insoles.
TR rubber compound
Outsole material of offloading shoes such as Relief Dual®.
Latex-free dressing material (tapes)
Skin-friendly material for pre-cut, elastic stabilization straps.
Locations
Raisting
DEHeadquarters, production, European distribution center
- Materials
- Plastics (EVA, PE, PU, Poron®, textiles)
- 3D printer (R&D)
Huntington, WV
USDARCO International, Inc. – USA headquarters
Halesworth, Suffolk
GBDARCO UK (V-M Orthotics Ltd., UK distribution)
Dharwad, Karnataka
INDARCO Medical India Pvt. Ltd. (distribution)
Shanghai
CNDARCO International Trading Shanghai Co. Ltd. (distribution), production since 1996
Products and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Design and development of orthopedic aidsEngineering | – | – | – | – | – |
| Manufacture of orthopedic aids (medical devices Class I)Assembly | – | – | – | – | – |
| In-house production of osteosynthesis products (foot surgery implants)Joining | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| 3D printer | – | – | – | – | DARCO (Europe) GmbH, Raisting |
Additional services
Reference customers
Quality and Certification
The externally certified quality management system in accordance with DIN EN ISO 13485 covers all DARCO areas and ensures product quality as well as service performance. All products carry CE marking with declaration of conformity and unique UDI marking (DataMatrix code, batch and traceability via detachable labels) in accordance with EU Medical Device Regulation 2017/745 (MDR).
| Evidence | Raisting |
|---|---|
| ISO 9001 | |
| ISO 13485 | |
| ISO 14001 | |
| MDR compliance (CE, UDI) |
Company History
- 1985
Founded by Dr. H. Darrel Darby; the first MedSurg™ Post-OP shoe is launched on the US market.
- 1987
DARCO International, Inc. relocates its headquarters to Huntington, West Virginia, USA.
- 1992
Foundation of the European distribution center DARCO (Europe) GmbH in Dießen am Ammersee; own implants for foot surgery.
- 1996
Establishment of the company's own production in China; cooperation with the GFFC.
- 1999
Certification in accordance with ISO 9001.
- 2003
Construction of the new company headquarters in Raisting, Upper Bavaria.
- 2004
Certification in accordance with ISO 13485.
- 2005
In-house production of osteosynthesis products at DARCO (Europe); Square-Toe Design.
- 2008
Portfolio expansion into sports and physiotherapy.
- 2012
Opening of DARCO Medical India Pvt. Ltd. in Dharwad.
- 2013
Diabetes and wound care programs.
- 2015
30th company anniversary; Relief Dual® is added to the German statutory health insurance (GKV) aids directory.
- 2018
Market entry into Great Britain with a new company headquarters (DARCO UK).
- 2020
35th company anniversary.
- 2021
Successful MDR transition.
- 2024
ISO 14001 certification; launch of the Movilo® therapeutic comfort shoe; groundbreaking for a new warehouse.
- 2025
40th company anniversary; new corporate design.