External prostheses and orthosesUpper extremity prostheses
Transradial prostheses (for amputation under elbow)
EMDN code Y061809
Manufacturers registered in Europe (EUDAMED) 7
- 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) 24
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 |
|---|---|---|---|
| HUGH STEEPER LIMITED Present in Europe in other categories | United Kingdom | Wrist | 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 |
| DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD Present in Europe in other categories | China | – | registered |
| FILLAUER COMPANIES, INC. | United States | – | registered |
| GuangZhou Nuoning Medical Supplies Co.,Ltd Present in Europe in other categories | China | – | registered |
| HAINAN LUNARSEA PERSONAL CARE SUPPLIES SDN. BHD | China | – | registered |
| HOSPITAL EQUIPMENT MFG. CO. Present in Europe in other categories | India | – | registered |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | China | – | registered |
| Huzhou Universal Glove Company Limited | China | – | registered |
| JIANGXI JUNHONG SPORTING GOODS CO., LTD. | Cambodia | – | registered |
| LA POINTIQUE INTERNATIONAL LTD. | United States | – | registered |
| MedTech Acuna S.A. de C.V. | Mexico | – | registered |
| Medi USA, LP Present in Europe in other categories | United States | – | registered |
| Mobius Technologies | United States | – | registered |
| NORTH COAST MEDICAL, INC. Present in Europe in other categories | United States | – | registered |
| Oppo Medical Corp Present in Europe in other categories | Taiwan | – | registered |
| Plus Meditech Co., Ltd. Plant 2 | Taiwan | – | registered |
| Ramiko Co., Ltd | Taiwan | – | registered |
| SPECIAL PROTECTORS CO., LTD. Present in Europe in other categories | Taiwan | – | registered |
| TIBURON MEDICAL ENTERPRISES Present in Europe in other categories | United States | – | registered |
| TZY Shenq Enterprise Co., Ltd | Taiwan | – | registered |
| Teh Lin Prosthetic & Orthopaedic, Inc. | Taiwan | – | registered |
| Unite Medical, LLC | United States | – | registered |
| WELLTEX SPORTS CO., LTD. | Taiwan | – | registered |
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Related categories
- Upper extremity prostheses - other18 manufacturers
- Partial hand prostheses (including fingers prostheses)10 manufacturers
- Elbow disarticulation prostheses4 manufacturers
- Transhumeral prostheses (for amputation above elbow)3 manufacturers
- Wrist disarticulation prostheses3 manufacturers
- Shoulder disarticulation prostheses2 manufacturers
- Parent category : Upper extremity prostheses19 manufacturers