Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007518069

FEI Number

3007518069

Entity Name

ARJOHUNTLEIGH LOGISTICS

City/State/Country

Eindhoven Noord-Brabant, NL

Establishment Address

High Tech Campus 21, Eindhoven Noord-Brabant NL-5656 AE, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ArjoHuntleigh AB (Owner Number: 10036598)

Owner / Operator Contact Address

Hans Michelsensgatan 10, Malmo, SE-M 211 20, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WoundExpress Pump, WoundExpress Garment SARA PLUS (FOREIGN EXPORTER ONLY) Various Arjo slings

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-04-24
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2011-05-17

Official Correspondent

No official correspondent registered.

US Agent Details

Darren Demerritt Business: Arjo Inc Email: darren.demerritt@arjo.com Phone: (425) 3089587

Related Public Records

Same Entity

ArjoHuntleigh 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
3012292104	Arjo Dominican Republic	Itabo, Haina San Cristobal, DO
3010010434	Arjo Canada Inc.	Mississauga Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

Similar Registrations

Registration Number	Establishment Name	Location
3033981998	KOYA MEDICAL, INC.	Dallas, TX, US
3020703724	Therma Bright Inc.	Toronto Ontario, CA
3014491159	AIROS MEDICAL INC	Audubon, PA, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007518069. Last updated year: 2026. Please use registration number 3007518069 when referencing this establishment in official correspondence.