HomeUSASunset Healthcare Solutions

Sunset Healthcare Solutions

USA · Chicago IL · www.sunsethcs.com
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
52listed device types
Class I 32Class II 20Class III 0
plus 155 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
17registered devices
Class I 11Class II 6
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
4active device licences
Class II 4
10 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States155 registration records, 2 510(k), 0 PMA
Brazil17 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: SUNSET HEALTHCARE SOLUTIONS Warehouse · Sunset Healthcare Solutions Central Warehouse · SUNSET HEALTHCARE SOLUTIONS, Inc. · SUNSET HEALTHCARE SOLUTIONS · Sunset Healthcare Solutions

Company information

Country
USA
City
Chicago IL
Website
www.sunsethcs.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
SUNSET HEALTHCARE SOLUTIONS, INC.
LEI
549300K5GLFDDIJIZJ70
Registration status
Active
Legal form
Business Corporation (corp.)
Incorporated
2009-10-19
Registered address
C/O STEPHEN R MILLER, CHICAGO, 60606
Registration authority
Business Services (Office of the Secretary of State), no. 67336852
Registry record updated
2024-01-14

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12011 · K102483
12021 · K201418

FDA listed device types

showing 8 of 52
Orthosis, Lumbar 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Regulator, Pressure, Gas Cylinder 1Mask, Gas, Anesthetic 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Unit, Filter, Membrane 1Stylet, Tracheal Tube 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201418Sunset Heated CPAP Tube2021-01-29
USK102483SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 1042011-09-13
BR81504790565Filtro para Concentradores de OxigênioClass I
BR81504799288Filtro Bacteriano/Viral Sunset InlineClass II
BR81504790571Filtro de Entrada de Bactérias para Concentradores de OxigênioClass I
CA98711AEROSOL MASKClass II
CA98746SOFT ADULT CANNULAClass II
CA100082TENS ELECTRONIC PULSE STIMULATOR FOR SORE MUSCLE RELIEFClass II

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