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COMFORT PRODUCTS, INC.

USA · Croydon

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia — 4 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

pendingnot queried

USUnited StatesFDA openFDA

30listed device types

Class I 28Class II 0Class III 0unclassified 2

plus 30 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 8Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

5registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

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 States30 registration records, 1 510(k), 0 PMA, 28 excluded

Brazil9 confirmed, 9 excluded

Saudi Arabia5 confirmed, 5 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: GUANGDONG COMFORT MEDICAL PRODUCTS CO., LTD. · COMFORT CARE PRODUCTS, LLC · COMFORT PRODUCTS, INC. · SAGE PRODUCTS LLC/COMFORT PERSONAL CLEANSING PRODUCTS · COMFORT PERSONNAL CLEANSING PRODUCTS · Sage Products LLC (Comfort Personal Cleansing Products)

FDA 510(k) clearances by year

11985 · K844176

FDA listed device types

showing 8 of 30

Pad, Eye 1Gauze / Sponge,Nonresorbable For External Use 1Mouthpiece, Breathing 1Mattress, Flotation Therapy, Non-Powered 1First Aid Kit Without Drug 1Radiographic Protective Glove 1Bedding, Disposable, Medical 1Solution, Isotonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K844176	PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS	1985-01-23
BR	10178010144	KIT DE ASPIRACAO E LIMPEZA ORAL Q-CARE (Q8º)	Class I
BR	10178010235	Bota Protetora Prevalon	Class I
BR	10178010237	SISTEMA DE POSICIONAMENTO PREVALON PADRÃO	Class I
SA	ME0000005960SFDAA00006	Sage M2 Microclimate Body Pad for use on top of Sage TAP Glide Sheet	—
SA	ME0000005960SFDAA00008	PrimaFit®	—

COMFORT PRODUCTS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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