HomeUSAGF Health Products, Inc.

GF Health Products, Inc.

USA · Atlanta
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 7 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
21listed device types
Class I 16Class II 5Class III 0
plus 24 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
6registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
6 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 6
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States24 registration records, 0 510(k), 0 PMA
Brazil2 confirmed, 1 excluded
Saudi Arabia6 confirmed, 0 excluded
Manufacturer names merged into this page: GF Health Products, Inc. · GF Health Products, Inc · GF HEALTH PRODUCTS, INC. · GF HEALTH PRODUCTS, INC · CORPORETE HEADQUARTERS: GF HEALTH PRODUCTS, INC

Company information

Country
USA
City
Atlanta

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.

FDA listed device types

showing 8 of 21
Chair, Surgical, Non-Electrical 1Cushion, Flotation 1Chair, Surgical, Ac-Powered 1Protector, Skin Pressure 1Wheelchair, Mechanical 1Adaptor, Hygiene 1Cover, Mattress (Medical Purposes) 1Aid, Transfer 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10229650044COLCHAO AQUATHERMClass I
BR10229659019COLCHÃO ANTI ULCERA POR PRESSÃO (ESCARAS) LUMEXClass I
SAME0000015960SFDAA00002LUMEX Drop Arm Commode
SAME0000015960SFDAA00001CLINICAL CARE RECLINER

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