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Engineered Medical Solutions Co., LLC

USA · Phillipsburg

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 5 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 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 States0 registration records, 2 510(k), 0 PMA, 18 excluded

Brazil1 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 3 excluded

Manufacturer names merged into this page: ENGINEERED MEDICAL SOLUTIONS CO. LLC · ENGINEERED MEDICAL SOLUTIONS Co. LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K133425	SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT	2013-12-05
US	K071180	SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001	2007-06-20
BR	80693249001	Safe-T-Surg	Class I
CA	97908	SCINTILLANT SURGICAL LIGHT	Class II

Engineered Medical Solutions Co., LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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