Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009107702

FEI Number

3009107702

Entity Name

Direct Healthcare Group Sverige AB

City/State/Country

Reftele Jonkoping, SE

Establishment Address

Industrigatan 2, Reftele Jonkoping 33375, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Direct Healthcare Group Sverige AB (Owner Number: 10037063)

Owner / Operator Contact Address

Industrigatan 2, Refele, SE-F 33375, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bure Stand Tall walker Walking table Bure Double 2 Belt MULTI, M, Rise & GO Walking table Bure Rise & Go Double, 75mm wheel Walking table Bure Rise & Go Double, PU, 75mm wheel Walking table Bure Double 2, PU Belt MULTI, L, Rise & GO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2011-06-14

Official Correspondent

Elisabet Lindberg

US Agent Details

Miriam Walls Business: xFDA Inc. Email: mwalls@xfda.com Phone: (703) 9195372

Related Public Records

Same Entity

Direct Healthcare Group Sverige AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009481053	Direct Healthcare Group Sverige AB	Kista Stockholm, SE

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3039346864	FIRST NATION GROUP, LLC	Niceville, FL, US
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3014214233	CORE MOBILITY SOLUTIONS	Los Gatos, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009107702. Last updated year: 2026. Please use registration number 3009107702 when referencing this establishment in official correspondence.