Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005619970

FEI Number

3005619970

Entity Name

Arjo (Suzhou) Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 158 Fangzhou Road, SIP, Suzhou, Jiangsu,, Suzhou Jiangsu 215024, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ARJOHUNTLEIGH AB (Owner Number: 8010077)

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

FLOWTRON ACS900 PUMP OPERATING ROOM (SUZHOU- MFR., POZNAN - COMPLAINTS) FLOWTRON ACS900 PUMP (SUZHOU - MFR., POZNAN - COMPLAINTS) BUBBLE PAD MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA RESPONSE PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) NIMBUS 3 PUMP (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) BREEZE MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA TRANCELL DELUXE PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) ACER PORTABLE LATERAL ROTATION SYSTEM (POZNAN - SPEC.DEVELOPER & POZNAN - COMPLAINTS) BREEZE PUMP (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT PUMP (SUZHOU - MANUFACTURER & POZNAN - COMPLAINTS) THERAKAIR VISIO MATTRESS (POZNAN - COMPLAINTS) AURA CUSHION (SUZHOU - MFR & POZNAN - COMPLAINTS) FIRST STEP ALL IN ONE (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT MATTRESSES (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA RESPONSE MATTRESS (POZNAN - SPEC. DEVELOPER, POZNAN - COMPLAINTS) AUTOLOGIC MATTRESS (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) THERAKAIR VISIO PUMP (POZNAN - COMPLAINTS) NIMBUS 4 PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) NIMBUS 4 MATTRESS ASSEMBLY RELIANT IS2 (SUZHOU - MFR & POZNAN - COMPLAINTS) PROFICARE (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AURA PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) FIRST STEP CIRRUS OVERLAY (SUZHOU - MFR & POZNAN - COMPLAINTS) NIMBUS PRO MATTRESS (SUZHOU - MFR & POZNAN - COMPLAINTS) MAXXAIR ETS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ATMOSAIR 9000AR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) NIMBUS 3 MATTRESS (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AUTOLOGIC PUMP (SUZHOU - SPEC.DEV & POZNAN - COMPLAINTS) CITADEL CONTROL UNIT AND MATTRESS (SUZHOU - SPEC. DEVELOPER & MANUFACTURER, POZNAN - COMPLAINTS, POZNAN - FOREIGN EXP) ATMOSAIR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP PLUS (SUZHOU - MFR & POZNAN - COMPLAINTS) ATMOSAIR 9000A (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ATMOSAIR APOD (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT HD (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AURALIS PUMP (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS) AURALIS MATTRESSES (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS) ATMOSAIR VELARIS MATTRESSES (POZNAN MFR, POZNAN COMPLAINTS) ATMOSAIR VELARIS PUMP (SUZHOU MFR, POZNAN COMPLAINTS) CAYLIS PUMP (SUZHOU MFR, POZNAN COMPLAINTS); CAYLIS MATTRESSES (SUZHOU MFR, POZNAN COMPLAINTS) FLOWTRON ACS800 PUMP OPERATING ROOM VARIANT (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) FLOWTRON ACS800 PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) TRI PULSE GARMENTS TRP10, TRP20, TRP30, TRP40 & TRP60L (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) Hydroven 12 Garments (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS, POZNAN - CONTRACT MFR) Hydroven 12 Pump (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS,SUZHOU- CONTRACT MFR) WoundExpress Garment WoundExpress Pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2015-06-25
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2002-08-15
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2014-04-30
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2016-08-23
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-09-07

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
3002806395	ARJOHUNTLEIGH AB	MALMO Skane, SE
9681684	ARJOHUNTLEIGH MAGOG, INC.	MAGOG Quebec, CA
3007420694	ArjoHuntleigh Polska Sp. zo.o.	Poznan Wielkopolskie, PL
1000589001	HUNTLEIGH HEALTHCARE LTD.	CARDIFF, SOUTH GLAMORGAN, GB

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005619970. Last updated year: 2026. Please use registration number 3005619970 when referencing this establishment in official correspondence.