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General Medical Equipment Corp.

USA · Sound Beach

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

4listed device types

Class I 2Class II 2Class III 0

plus 7 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

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 States7 registration records, 23 510(k), 0 PMA, 82 excluded

Brazil1 confirmed, 5 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: GENERAL MEDICAL CO. · GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. · ONCOVISION GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A.

Same-named companies — This database also contains companies with near-identical names: General Equipment For Medical Imaging, GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

41977

11980

21982

11983

11984

11985

21990

21991

11993

11997

12009

12011

22014

22016

12023

FDA listed device types

System, Tomography, Computed, Emission 1Device, Iontophoresis, Other Uses 1Probe, Uptake, Nuclear 1Camera, Scintillation (Gamma) 1

Market	Identifier	Name	Class / date
US	K232569	CAREMIBRAIN	2023-09-21
US	K162052	Sentinella 102, Sentinella 102 Horus	2016-08-18
US	K161631	MAMMI	2016-07-28
BR	81639910003	Sonda Detectora	Class II

General Medical Equipment Corp.

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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