External prostheses and orthoses
Upper extremity prostheses
EMDN code Y0618
Manufacturers registered in Europe (EUDAMED) 19
- 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) 79
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 |
|---|---|---|---|
| Teh Lin Prosthetic & Orthopaedic, Inc. | Taiwan | TEHLIN | registered |
| Myomo, Inc. Present in Europe in other categories | United States | MyoPro MyoPro 2+ MyoPro 2x MyoPro 2x Assembly Kit Mobile Arm Rehabilitation Kit version 2 (MARK2) Mobile Arm Rehabilitation Kit (MARK) | registered |
| TASKA PROSTHETICS LIMITED Present in Europe in other categories | New Zealand | MC Seal Ring Kit, Medium/Large, Sand TASKA Lamination Collar Kit (6-band), 45mm, Sand TASKA Lamination Collar Kit (6-band), 45mm, Black MC Seal Ring Kit, Small, Black MC Seal Ring Kit, Small, Sand Low Profile Lamination Kit, CX, 45mm | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| Manamed, Inc. | United States | ManaMed ManaEZ Shoulder Ice CureTech | registered |
| AETHER BIOMEDICAL SP Z O O | Poland | ZEUS Aether Battery System | registered |
| ALIMED, INC. | United States | HARNESS PAVLIK TYPE | registered |
| Elite Orthopaedics, Inc. | United States | Elite Orthopaedics | registered |
| ESPER, TOV | – | Esper Bionics | registered |
| Orthofix US LLC Present in Europe in other categories | United States | Trend | registered |
| Ideavillage Products Corp | United States | Copperfit | registered |
| FULLERTON MANUFACTURING LIMITED | Vietnam | Fullerton Manufacturing Limited | registered |
| Unite Medical, LLC | United States | Unite Medical® | registered |
| VIVE HEALTH LLC Present in Europe in other categories | United States | CoreTech | registered |
| AID UNITED INTERNATIONAL CO., LIMITED Present in Europe in other categories | China | – | registered |
| Alt-Bionics, Inc. | United States | – | registered |
| BENIK CORP. | United States | – | registered |
| Bioservo AB | Sweden | – | registered |
| CHANGZHOU MAJOR MEDICAL PRODUCTS CO., LTD. | China | – | registered |
| Changzhou Meiguan Care Products Technology Co.,LTD. | China | – | registered |
| Cixi Cijia Handicraft Co. Ltd | China | – | registered |
| Coapt, LLC | United States | – | registered |
| DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD Present in Europe in other categories | China | – | registered |
| DYNAMIC TECHNO MEDICALS PRIVATE LIMITED | India | – | registered |
| Dongguan Ellian Enterprise, LTD. | China | – | registered |
| ESPER LLC. | Ukraine | – | registered |
| Elastic Therapy LLC Present in Europe in other categories | United States | – | registered |
| FILLAUER COMPANIES, INC. | United States | – | registered |
| Foshan Hongfeng Co., Ltd. Present in Europe in other categories | China | – | registered |
| Frogfish International Corp. | Taiwan | – | registered |
| GUARDMED HEALTHCARE KH CO., LTD. | Cambodia | – | registered |
| GuangZhou Nuoning Medical Supplies Co.,Ltd Present in Europe in other categories | China | – | registered |
| HAINAN LUNARSEA PERSONAL CARE SUPPLIES SDN. BHD | China | – | registered |
| HANGZHOU WEIZE IMP & EXP CO., LTD | China | – | registered |
| HOSPITAL EQUIPMENT MFG. CO. Present in Europe in other categories | India | – | registered |
| HUBEI YJT INTELLIGENT TECHNOLOGY GROUP CO., LTD. (formerly k | China | – | registered |
| Hebei Cairun Technology Co. LTD | China | – | registered |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | China | – | registered |
| Hengshui Runde Medical Instruments Co.,Ltd | China | – | registered |
| Huzhou Universal Glove Company Limited | China | – | registered |
| Irufa Industrial Group Present in Europe in other categories | Taiwan | – | registered |
| JIANGXI JUNHONG SPORTING GOODS CO., LTD. | Cambodia | – | registered |
| JIUNDAR INDUSTRIAL CO., LTD. | Taiwan | – | registered |
| Jkh Health Co., Ltd. Present in Europe in other categories | China | – | registered |
| KAO CHEN ENTERPRISE CO., LTD. | Taiwan | – | registered |
| Kinova | Canada | – | registered |
| LA POINTIQUE INTERNATIONAL LTD. | United States | – | registered |
| Magway Trading Inc. | Canada | – | registered |
| Mand.ro Co., Ltd. | South Korea | – | registered |
| MedTech Acuna S.A. de C.V. | Mexico | – | registered |
| Medex Medical Supplies Ltd. | China | – | registered |
| Medi USA, LP Present in Europe in other categories | United States | – | registered |
| Metacare Industrial LTD | China | – | registered |
| Miracle Medical Industries Present in Europe in other categories | Egypt | – | registered |
| Mobius Technologies | United States | – | registered |
| NORTH COAST MEDICAL, INC. Present in Europe in other categories | United States | – | registered |
| Ningbo MDC Import & Export Co, LTD. | China | – | registered |
| OPTEC USA, INC. Present in Europe in other categories | United States | – | registered |
| OSSUR Americas | United States | – | registered |
| Open Bionics Present in Europe in other categories | United Kingdom | – | registered |
| Oppo Medical Corp Present in Europe in other categories | Taiwan | – | registered |
| PAIFU COMFORT INDUSTRIAL CO LTD | Taiwan | – | registered |
| PROFESSIONAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| PSYONIC | United States | – | registered |
| Plus Meditech Co., Ltd. Plant 2 | Taiwan | – | registered |
| Ramiko Co., Ltd | Taiwan | – | registered |
| SEISA MEDICAL INC. d.b.a Tekni-Plex Healthcare | United States | – | registered |
| SPECIAL PROTECTORS CO., LTD. Present in Europe in other categories | Taiwan | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Shenzhen Bairunheng Technology Co., Ltd. | China | – | registered |
| TIBURON MEDICAL ENTERPRISES Present in Europe in other categories | United States | – | registered |
| TZY Shenq Enterprise Co., Ltd | Taiwan | – | registered |
| Trend Medical, Inc. | United States | – | registered |
| United Fortune International, Inc. Present in Europe in other categories | United States | – | registered |
| WELLTEX SPORTS CO., LTD. | Taiwan | – | registered |
| YANGZHOU QIANGJING SPORTS PRODUCTS CO.,LTD | China | – | registered |
| YEARSTAR HEALTHCARE TECHNOLOGY CO., LTD. Present in Europe in other categories | China | – | registered |
| Yangzhou Aolikes Sports Goods Co., Ltd. Present in Europe in other categories | China | – | registered |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. Present in Europe in other categories | China | – | registered |
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