External prostheses and orthoses
Orthotic shoes
EMDN code Y0633
Manufacturers registered in Europe (EUDAMED) 74
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 212
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| MD ORTHOPAEDICS, INC. Present in Europe in other categories | United States | Rhino MD Orthopaedics Mitchell Ponseti® Bracing System Ponseti® Lite | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| Bird & Cronin, LLC | United States | KELLEY CAST BOOT OPEN XS KELLEY CAST BOOT OPEN MD KELLEY CAST BOOT OPEN SM KELLEY CAST BOOT OPEN XL COMFOR LITE CAST BOOT XL KELLEY CAST BOOT OPEN MD/LG | registered |
| VIVE HEALTH LLC Present in Europe in other categories | United States | Vive CoreTech Vive Health Vivesole | registered |
| POSITION HEALTH, LLC Present in Europe in other categories | United States | GAITKEEPER® Cast Shoe Position Health® Classic Post-Op Shoe | registered |
| TETRA MEDICAL SUPPLY CORP. | – | – | registered |
| DJO, LLC | United States | PROCARE AIRCAST DONJOY | registered |
| Elite Orthopaedics, Inc. | United States | Elite Orthopaedics | registered |
| TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO.,LTD. Present in Europe in other categories | China | Tairuibosi | registered |
| Asp Global, LLC | United States | PERFORMANCE HEALTH | registered |
| BAILEY INSTRUMENTS LTD | United Kingdom | Bailey Versatile Insole Small (Size 3- 5) Bailey Versatile Comfort 3/4 Insole - X Large (Size 12-14) Bailey Versatile Comfort 3/4 Insole - Large (Size 9-11) Bailey Versatile Comfort 3/4 Insole - Small (Size 3-5) Bailey Versatile Comfort 3/4 Insole - Medium (Size 6-8) Bailey Versatile Insole Large (Size 9 - 11) | registered |
| Cadense, Inc. | United States | Cadense | registered |
| Shenzhen Yuechuan trade Co., Ltd. Present in Europe in other categories | China | InhwRior | registered |
| Guangzhou Xinbo Electronic Co., Ltd. Present in Europe in other categories | China | DR-HO'S | registered |
| AB Ortopedijos technika Present in Europe in other categories | Lithuania | – | registered |
| AETREX WORLDWIDE, INC. | United States | – | registered |
| ALLMAY INTERNATIONAL LIMITED | Hong Kong SAR China | – | registered |
| AMC GLOBAL (CAMBODIA) CO., LTD | Cambodia | – | registered |
| AMERICAN ORTHO-TECH (P), LTD. | India | – | registered |
| APEX VIET NAM FOOTWEAR COMPANY LIMITED | China | – | registered |
| Abletech Orthopedics Corporation | China | – | registered |
| Action Packaging | United States | – | registered |
| Alkan Ayakkabi Ve Deri Mam. SAN VE TIC. LTD. STI. | Türkiye | – | registered |
| Allmay Bodywear (Shenzhen) Co., Ltd | China | – | registered |
| Anodyne | United States | – | registered |
| Apothecaries Sundries Mfg Pvt Ltd | India | – | registered |
| B & S PARTNERS INC. dba Pilgrim Shoes | United States | – | registered |
| BANDAGE-EN CORSETINDUSTRIE BASKO B.V. | Netherlands | – | registered |
| BANGNI (VIETNAM) INDUSTRIAL COMPANY LIMITED | Vietnam | – | registered |
| BILLY FOOTWEAR | United States | – | registered |
| Barbaras Development, Inc. | United States | – | registered |
| Bauerfeind AG Present in Europe in other categories | Germany | – | registered |
| Bay Footwear Limited | Bangladesh | – | registered |
| Blunding S.A. | Chile | – | registered |
| Bort GmbH Present in Europe in other categories | Germany | – | registered |
| BraceAbility, Inc. | United States | – | registered |
| Breg, Inc. Present in Europe in other categories | United States | – | registered |
| Brooks Running | United States | – | registered |
| Buy Asia Enterprise Ltd | China | – | registered |
| C-Pro Direct Ltd Present in Europe in other categories | United Kingdom | – | registered |
| CAIRS,LLC | United States | – | registered |
| CALERES, INC. Present in Europe in other categories | United States | – | registered |
| CAMHUI FOOTWEAR TECH CO., LTD. | Cambodia | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CMS Sports Inc. | United States | – | registered |
| COMFORT PLUS CORPORATION | Taiwan | – | registered |
| COMMERCE ATLANTIC CORP. | United States | – | registered |
| COMPEDICA LIMITED Present in Europe in other categories | Isle of Man | – | registered |
| Chooseyourshoes Philippines (CYS-PH) Inc | Philippines | – | registered |
| Comfortland International, LLC | United States | – | registered |
| Core Products International, Inc. Present in Europe in other categories | United States | – | registered |
| DING XING FOOTWEAR CO., LTD | Vietnam | – | registered |
| DONGGUAN JIUHUI INDUSTRIAL LIMITED Present in Europe in other categories | China | – | registered |
| DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD Present in Europe in other categories | China | – | registered |
| DRD Footwear, LLC | United States | – | registered |
| DYNAMIC TECHNO MEDICALS PRIVATE LIMITED | India | – | registered |
| Dongguan City Dong Cheng Shoes Material Co.,Ltd | China | – | registered |
| Dongguan Jinsheng Shoes Material Manufactory | China | – | registered |
| Dongguan KIO Electronic Materials Co., Ltd | China | – | registered |
| Dongguan Yun Chang Plastic Co., Ltd. | China | – | registered |
| Drtv Asia, Ltd. | China | – | registered |
| Dynasplint Systems, Inc. | United States | – | registered |
| EDSER INSOLES S.L. | Spain | – | registered |
| Earthwalk Orthotics Acquisition Company, LLC | United States | – | registered |
| Elastic Therapy LLC Present in Europe in other categories | United States | – | registered |
| Ergoactives, LLC Present in Europe in other categories | United States | – | registered |
| FREEVIEW INDUSTRIAL (VIETNAM) CO., LTD | Vietnam | – | registered |
| Fenglin Industry Co., Ltd. | China | – | registered |
| Fior & Gentz Gesellschaft fuer Entwicklung und Vertrieb von | Germany | – | registered |
| Footmaxx of Virginia | United States | – | registered |
| Fujian Quanzhou UnionWin Trading Co., Ltd. | China | – | registered |
| Fung Lead Medical & Sports Co., Ltd. Present in Europe in other categories | Taiwan | – | registered |
| Fung Yin Industrial Co Ltd | Taiwan | – | registered |
| Fuzhou Fushunying Sports Goods Co., Ltd | China | – | registered |
| G-Foremost Company Limited | Vietnam | – | registered |
| GUANGZHOU LEAD FAIR PLASTIC CO., LTD. | China | – | registered |
| Golden Star Company Limited - Branch | Vietnam | – | registered |
| Golden Star Srl Present in Europe in other categories | Italy | – | registered |
| Guangdong Junfeng BFS Technology Co., Ltd. | China | – | registered |
| Guangzhou New Design Biotechnology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Guangzhou Wenzheng Jiasheng Network Technology Co LTD | China | – | registered |
| HEFEI MLUSH SANITARY PRODUCTS CO.,LTD | China | – | registered |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | China | – | registered |
| Hengshui Jingkang Medical Device Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Hengshui Runde Medical Instruments Co.,Ltd | China | – | registered |
| Hengshui Xukang Medical Appliances Co., Ltd. Present in Europe in other categories | China | – | registered |
| Hersco Ortho Labs | United States | – | registered |
| Homeway Technology Co. Ltd. | Taiwan | – | registered |
| Hong Ming Enterprise Co., Ltd. | Taiwan | – | registered |
| Hospital & Homecare Imp. & Exp. Co., Ltd | China | – | registered |
| Hue Light co., Ltd | South Korea | – | registered |
| Human Performance Lab Co.,Ltd. | South Korea | – | registered |
| INDIA SHOES EXPORTS PVT LTD | India | – | registered |
| Invent Medical USA, LLC | United States | – | registered |
| JIUNDAR INDUSTRIAL CO., LTD. | Taiwan | – | registered |
| JOIN ENTERPRISE, LTD. | South Korea | – | registered |
| Jiangmen Shutoria Shoes Co Ltd | China | – | registered |
| Jianxing Shoe Co. Ltd. | China | – | registered |
| KNIGHT ENGINEERING SOLUTIONS, LLC | United States | – | registered |
| Kenetrek LLC | United States | – | registered |
The 100 most active manufacturers are shown, out of 212.
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