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QUALITY ELECTRODYNAMICS, LLC.

USA · Mayfield Village

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 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

5listed device types

Class I 1Class II 4Class III 0

plus 40 registration records and 34 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

19 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

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 States40 registration records, 34 510(k), 0 PMA

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: QUALITY ELECTRODYNAMICS · QUALITY ELECTRODYNAMICS, LLC.

FDA 510(k) clearances by year

12007

22008

12009

12010

22011

32012

32014

42015

52016

22017

32018

22020

12023

22024

22025

FDA listed device types

Coil, Magnetic Resonance, Specialty 1System, Nuclear Magnetic Resonance Spectroscopic 1Accelerator, Linear, Medical 1System, Nuclear Magnetic Resonance Imaging 1Instrument, Quality-Assurance, Radiologic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K244054	16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)	2025-02-28
US	K242006	SureWave Elastography (Q7000225)	2025-02-12
US	K233652	Contour Hand/Wrist (Q7000232)	2024-02-16

QUALITY ELECTRODYNAMICS, LLC.

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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