Manufacturer

Orthotech Rehabilitation

ChinaLegal entities : Orthotech Rehabilitation Co., Ltd.

First countries of placing on the market declared in EUDAMED : Austria, Belgium, Germany, Greece, Ireland, Italy, Netherlands, Poland, Romania, Spain, Sweden

EU representative : SUNGO Europe B.V. (Netherlands)

Ramon.Tseng@wellcare-supports.com

14 categories, 17 models including 17 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Orthoses, foot (including insoles and inserts)	Y061203	5th Toe Bunion Shield3 refs Full Length Insole:640001 Heel Cup Central Spur:640004 Heel Cushion With Removable Pad:640006 “U” Shaped Heel Cushion:640008 Full Length Cushioning Insole:640009 3/4 Arch Support:640010 3/5 Arch Support:640010 etc3 refs	I MDR	EUDAMED record Report an error
Passive ankle-foot orthoses	Y06120601	Athena Calf Support Plantar Fasciitis Compression Sock:610002 Diabetic Antibacterial Socks:610003 Diabetic Daily Socks:6100043 refs Walking Boot:635101 Air Walking Boot:635102 Super Air Walking Boot:635103 Super Walking Boot:635104 ROM Walking Boot:635201 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 etc3 refs	I MDR	EUDAMED record Report an error
Shoulder orthoses	Y060621	Mesh Sling:210001 TC Sling:210002 Universal Swathe Sling:210003 Shoulder Support:210004 Humeral Fracture Brace:210005 Shoulder Immobilizer:210008 Shoulder Abduction Immobilizer:213101 Pillow Arm ABD Immobilizer:213103 etc3 refs Posture Support Brace:220001 Posture Corrective Brace:220002 Universal Clavicle Support:220003 Clavicle Support:220004 Posture Corrector:220005 Clavicle Support:2200063 refs	I MDR	EUDAMED record Report an error
Cervical spine orthoses	Y060312	Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 K Collar:1214013 refs	I MDR	EUDAMED record Report an error
Cervicothoracic spine orthoses	Y060315	Minerva CTO	I MDR	EUDAMED record Report an error
Elbow orthoses	Y060615	Elbow Strap With Pad:310002 Elbow Strap:310003 Airform Elbow Strap:310004 Neoprene Elbow Sleeve:310005 Airform Elbow Strap:310006 Tennis Elbow Brace:310007 Tennis Elbow Air Brace:310008 etc3 refs	I MDR	EUDAMED record Report an error
Heel, elbow and knee anti-decubitus protection aids	V0811	AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:6200163 refs	I MDR	EUDAMED record Report an error
Hip orthoses (including abduction orthoses)	Y061215	Counter Hip Brace 260001(L/Left/Black)3 refs	I MDR	EUDAMED record Report an error
Knee orthoses	Y061209	Athena Knee Support Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002 DAILY OA KNEE BRACE:5250043 refs	I MDR	EUDAMED record Report an error
Lumbosacral spine orthoses	Y060308	Abdominal Binder 230001 Elastic Lumbar Support 231201 Lumbar Stabilizer 231206 Lumbar Support With Stays 231202 Lumbar Support With Stays 238001 Lumbofit Panel Brace 231303 Lumbofit Support 231302 Lumbosacral Support 231204 etc3 refs	I MDR	EUDAMED record Report an error
Sacroiliac spine orthoses	Y060303	RPS KNIT S1 BELT3 refs	I MDR	EUDAMED record Report an error
Thigh orthoses	Y061217	Athena Thigh Support3 refs	I MDR	EUDAMED record Report an error
Thoracolumbar orthoses	Y060306	Jewett Hyperextension Brace3 refs	I MDR	EUDAMED record Report an error
Wrist (forearm) orthoses	Y060609	Athena Wrist Support Universal Wrist Brace:410001 Wrap-around Wrist Brace:410002 Wrist/ Forearm Splint:410003 Wrist Brace:410004 Wrist Brace:410005 Wrist Splint:410006 Wrist Brace:410007 Universal Wrist Splint:410008 etc3 refs	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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