Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006532285

FEI Number

3006532285

Entity Name

Touch Bionics Ltd

City/State/Country

Livingston West Lothian, GB

Establishment Address

Integration House, Alba Business Park, Livingston West Lothian EH54 7EG, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSSUR Americas (Owner Number: 9026971)

Owner / Operator Contact Address

200 Spectrum Center Drive, Suite 700, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Thigh Sleeve Relax Night Care Stump Shrinker i-limb skin natural Comfort SCS i-limb skin match Volume Compensation Sock Livingskin Partial finger Livingskin Toe Livingskin Full hand Livingskin Finger band Livingskin Below elbow Livingskin Partial hand Livingskin Foot Livingskin Full finger Livingskin Above Elbow Livingskin PIPDriver® MCPDriver® ThumbDriver® GripLock Finger® i-Limb Ultra Demo-limb i-LIMB Skin Active i-Limb Quantum i-Digits i-Digits Quantum i-Limb Ultra Titanium i-Digits Access i-Limb Access My Biosim Virtu-limb i-LIMB Skin Natural Biosim Pro i-LIMB Skin Contour My i-Limb i-Limb access titanium Biosim

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2016-12-15
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2004-01-07
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2017-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Katla Axelsdottir Business: Ossur Email: kaxelsdottir@ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

OSSUR Americas

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008395545	OSSUR	Newburgh, NY, US
3008523132	Ossur Mexico	Tijuana Baja California, MX
3010405373	Ossur Orlando	Orlando, FL, US
3003764610	Ossur Iceland ehf.	REYKJAVIK, IS
3004161950	OSSUR EUROPE B.V.	Eindhoven Noord-Brabant, NL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006532285. Last updated year: 2026. Please use registration number 3006532285 when referencing this establishment in official correspondence.