Manufacturer

BioSkin

United StatesLegal entities : BioSkin LLC

Markets : Germany · Netherlands · United States

Approvals : EU – class I · United States (FDA) – · class I, II

EU representative : Rollerwerk Medical Engineering & Consulting (Germany)

Website

9 categories, 36 models including 33 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
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Knee orthoses	Y061209	GLADIATOR L3 refs HINGED KNEE SLEEVE L3 refs Knee Sleeve L 41100O3 refs OA Spiral L3 refs PATELLA STABILISATOR CONFORMA HINGE L3 refs 9 others PATELLA STABILISATOR L3 refs PREMIUM J CONFORMA HINGE L3 refs Q Baby Patellar Tendon Strap - XS-M2 refs Q BRACE CrossFire L3 refs Q BRACE OPEN PATELLA L3 refs Q BRACE WRAPAROUND L3 refs Q LOK DYNAMIC PATELLA TRACTION S Q LOK ROM M VISCO CROSSFIRE CONFORMA HINGE L2 refs	I MDR	EUDAMED record Report an error
Passive ankle-foot orthoses	Y06120601	AFTR DC M-L3 refs AFTR Pull-On with Gel M-L2 refs AFTR Pull-On XS-S Pneumatic Short Walking Boot 33033 refs STO ANKLE BRACE L3 refs 2 others TRILOK L3 refs Ankle Sleeve Wrap L3 refs (no longer marketed)	I MDR	EUDAMED record Report an error
Orthoses, foot (including insoles and inserts)	Y061203	HCS (Hallux Control Strap) + CMC Wrap L Single2 refs HCS (Hallux Control Strap) 10Pack L3 refs Weil Osteotomy Strap Universal Weil Strap + CMC Wrap Bundle Universal	I MDR	EUDAMED record Report an error
Wrist-hand orthoses	Y060612	DP2 M-L3 refs DP3 M-L3 refs WRIST-THUMB SPICA M-L3 refs	I MDR	EUDAMED record Report an error
Elbow orthoses	Y060615	STANDARD ELBOW SLEEVE L3 refs TENNIS ELBOW BAND L3 refs Tennis Elbow Sleeve L3 refs (no longer marketed)	I MDR	EUDAMED record Report an error
Lumbosacral spine orthoses	Y060308	LUMBAR SUPPORT BRACE 4XL3 refs STANDARD BACK SKIN L3 refs (no longer marketed)	I MDR	EUDAMED record Report an error
Fingers orthoses	Y060603	THUMB SPICA L-XXL2 refs	I MDR	EUDAMED record Report an error
Lower limb orthoses - accessories	Y061280	Mittelfussbandage (CMC Wrap) Universal	I MDR	EUDAMED record Report an error
Wrist (forearm) orthoses	Y060609	BOOMERANG Universal	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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