Manufacturer

Össur Iceland ehf

IcelandLegal entities : Össur Iceland ehf.

First countries of placing on the market declared in EUDAMED : Netherlands

26 categories, 99 models including 99 on the market, 1 country

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
Lower extremity prostheses - other	Y062499	4-Hole Female Pyramid Adapter Rotation SS BU000703 refs AeroFit® Seal-In BU001093 refs Comfort SCS BU000593 refs Icelock® 125 Ratchet BU000763 refs Icelock® 234 Lanyard BU000903 refs 8 others Icelock® 544 E2 Connector BU000783 refs Icelock® 562 Hybrid Passive Vacuum BU000983 refs Iceross Seal-In® Socks BU000103 refs Iceross® Distal Cup BU000083 refs Iceross® Interface Sheath BU00009 Knee Rotation Adapter BU00101 Protector Sleeve BU000893 refs Unity® BU000583 refs	I MDR	EUDAMED record Report an error
Transtibial prostheses (for amputation under knee)	Y062409	4Seal Classic BU000013 refs AKOS BU000033 refs Genu Sleeve BU000073 refs Iceform® Cushion BU000113 refs Iceform® Locking BU000053 refs 6 others Iceross Comfort® Cushion BU000023 refs Iceross Seal-In® X Locking BU000133 refs Iceross® Post-Op TF BU000143 refs Iceross® Sleeve BU000063 refs Proprio Foot® BU000483 refs Össur Rigid Dressing BU000152 refs	I MDR	EUDAMED record Report an error
Foot partial prostheses (including toe prostheses)	Y062403	Aspire™ Foot BU000453 refs Balance™ Foot S Torsion BU000513 refs Cheetah Junior BU000503 refs Chopart BU000473 refs Flex-Foot® Balance BU000493 refs 4 others Flex-Foot® Balance with D/P Flexion BU000443 refs Nike Sole BU001003 refs Pro-Flex® LP BU000463 refs Torsion Shock Adapter BU000953 refs	I MDR	EUDAMED record Report an error
Transfemoral prostheses (for amputation above knee)	Y062415	AeroFit® Socket BU000123 refs Aspire™ H1 BU000543 refs Aspire™ M1 BU000603 refs Aspire™ M3 BU000553 refs Connect® TF BU000973 refs 4 others Knee lanyard kit for Connect® TF BU00108 Navii® BU000533 refs Power Knee Battery BU00106 Power Knee™ BU000523 refs	I MDR	EUDAMED record Report an error
Knee orthoses	Y061209	C180™ Rocket BU000183 refs CTi® OA BU000373 refs Exoform® Knee Immobilizer BU000363 refs Extreme® BU000353 refs Formfit® Hinged Knees BU000163 refs 3 others Formfit® Pro Knee BU001033 refs Formfit® Tracker BU000193 refs Rebound® ACL BU000673 refs	I MDR	EUDAMED record Report an error
Lower limb orthoses - accessories	Y061280	Achilles Heel Wedge BU000823 refs Belt Extender BU000923 refs CTi®3 Impact Guard BU001023 refs CTi®3 PCL Strap Kit BU001073 refs Foam Wedge BU00087 3 others Formfit® Knee Buttress BU00112 OR kit BU00086 Ski boot attachment BU00084	I MDR	EUDAMED record Report an error
Passive ankle-foot orthoses	Y06120601	AFO Dynamic BU000303 refs AirForm® Night Splint BU000313 refs AirForm® Pre-inflated Ankle Stirrup BU000293 refs DH Offloading Walker BU000743 refs Formfit® Ankle BU000273 refs 2 others Formfit® Pro Ankle BU000203 refs Formfit® Walker BU000323 refs	I MDR	EUDAMED record Report an error
Partial hand prostheses (including fingers prostheses)	Y061803	GripLock Finger® BU001173 refs i-Digits® BU000563 refs Livingskin® BU001113 refs MCPDriver® BU001163 refs PIPDriver® BU001183 refs	I MDR	EUDAMED record Report an error
Cervical spine orthoses	Y060312	Miami Jr® BU000683 refs Miami JTO® Thoracic Extension BU000233 refs Universal Cervical Collar BU000793 refs	I MDR	EUDAMED record Report an error
Elbow orthoses	Y060615	Formfit® Pro Elbow BU000283 refs Formfit® Tennis Elbow BU000253 refs Rebound® Post-Op Elbow BU000262 refs	I MDR	EUDAMED record Report an error
Hip orthoses (including abduction orthoses)	Y061215	Rebound® Hip BU000333 refs Unloader® Hip BU000343 refs	I MDR	EUDAMED record Report an error
Orthoses, foot (including insoles and inserts)	Y061203	Canvas Rocker Bottom Cast Shoe BU000773 refs SoftWalk Insoles BU001053 refs	I MDR	EUDAMED record Report an error
Ready-made orthotic shoes	Y063303	DH Offloading Post-Op Style Shoe BU000733 refs Mesh Top Post-Op Shoe Female BU000753 refs	I MDR	EUDAMED record Report an error
Shoulder-elbow-wrist- hand orthoses	Y060630	Bergschultz Universal Arm Sling BU000653 refs Formfit® Shoulder Brace BU000663 refs	I MDR	EUDAMED record Report an error
Spinal orthoses - accessories	Y060380	AMS Sleeves BU000853 refs Anterior panels BU000813 refs	I MDR	EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - software accessories	Z129082	Biosim Pro BU001043 refs Össur Logic BU00099	I MDR	EUDAMED record Report an error
Wrist-hand orthoses	Y060612	Elastic Thumb Spica BU000423 refs Formfit® Pro Wrist BU000723 refs	I MDR	EUDAMED record Report an error
Abdominal orthoses - other	Y060499	Elastic Abdominal Binder BU000213 refs	I MDR	EUDAMED record Report an error
Aesthetic fillers, calf and thigh	Y062703	Calf cosmesis BU000613 refs	I MDR	EUDAMED record Report an error
External prostheses and orthoses - other	Y0699	Hot/Cold Therapy Gel Pad BU000943 refs	I MDR	EUDAMED record Report an error
Lumbosacral spine orthoses	Y060308	Formfit® Back Support BU000383 refs	I MDR	EUDAMED record Report an error
Orthoses, upper extremity - other	Y060699	Figure-8 Clavicle Splint BU000243 refs	I MDR	EUDAMED record Report an error
Thoracic orthoses	Y060307	Universal Elastic Rib Belt BU000412 refs	I MDR	EUDAMED record Report an error
Thoracolumbosacral spine orthoses	Y060309	Miami Lumbar® Posteo BU000633 refs	I MDR	EUDAMED record Report an error
Upper extremity prostheses - other	Y061899	Iceross® Upper-X Locking BU000043 refs	I MDR	EUDAMED record Report an error
Upper limb orthoses - accessories	Y060680	Axilla Pillow BU000912 refs	I MDR	EUDAMED record Report an error

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