HomeUSASAFE N SIMPLE LLC

SAFE N SIMPLE LLC

USA · Clarkston
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
14listed device types
Class I 12Class II 0Class III 0unclassified 2
plus 21 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
0valid device licences
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 States21 registration records, 0 510(k), 0 PMA, 10 excluded
Brazil1 confirmed, 2 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SAFE N SIMPLE LLC · SAFE N SIMPLE · Safe N Simple LLC

Company information

Country
USA
City
Clarkston

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 14
Dressing, Wound, Hydrophilic 1Appliance, Colostomy, Disposable 1Solvent, Adhesive Tape 1Dressing, Wound, Occlusive 1Device, Intravascular Catheter Securement 1Burn Kit Without Drug 1Cement, Stomal Appliance, Ostomy 1Tape And Bandage, Adhesive 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80299880108Safe n Simple - protetor cutâneoClass II
SAME0000003760SFDAA00013DermaPro

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