Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681133

FEI Number

3005564811

Entity Name

FILLAUER EUROPE

City/State/Country

JARFALLA Stockholm, SE

Establishment Address

KUNG HANS VAG 2, 192 68 SOLLENTUNA, JARFALLA Stockholm --, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FILLAUER COMPANIES, INC. (Owner Number: 9910012)

Owner / Operator Contact Address

2710 AMNICOLA HWY., Chattanooga, TN 37406, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Foot Orthotics SPL CTO RGO Clinical Trial Orthosis (CTO) Hand Shell Footshell NEO Axilla Loop Padding Procover Arm Skinz Foam Cover Dreamskin Natural Definition cosmetic gloves and covers Absolute Sleeve Mechanical Hands Passive Hands Prosthetic Recreational Terminal Devices Prosthetic Valves MightyMite Components Shuttle Lock Endoskeletal Alignment System ALP adaptors Clutch Lock AP&ML Unit Gator Grip Wrist Lock Structural Components Prosthetic Alignment Devices

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1992-08-05
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2003-04-09
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2002-05-31
ISP	Valve, Prosthesis	Physical Medicine	Class 1	890.3420	2004-04-21
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2003-04-09

Official Correspondent

Annette Cole

US Agent Details

Annette Cole Business: FILLAUER LLC Email: acole@fillauer.com Phone: (423) 6240946

Related Public Records

Same Entity

FILLAUER COMPANIES, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1723997	MOTION CONTROL, INC.	SALT LAKE CITY, UT, US
3007510149	Fillauer Composites	Salt Lake City, UT, US
1022826	FILLAUER, LLC	CHATTANOOGA, TN, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681133. Last updated year: 2026. Please use registration number 9681133 when referencing this establishment in official correspondence.