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Shore Medical, Inc.

USA · Vista

✓ 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

18listed device types

Class I 0Class II 17Class III 1

plus 50 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

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

pendingnot queried

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 States50 registration records, 4 510(k), 0 PMA, 2 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: BAY SHORE MEDICAL EQUIPMENT, LLC · SHANGAI SUN-SHORE MEDICAL INSTRUMENTS CO., LTD

FDA 510(k) clearances by year

11989 · K892342

11990 · K904397

11992 · K922814

11998 · K982193

FDA listed device types

showing 8 of 18

Image-Intensified Fluoroscopic X-Ray System, Mobile 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Nuclear Magnetic Resonance Imaging 1System, X-Ray, Mobile 1System, Tomography, Computed, Emission 1Full Field Digital, System, X-Ray, Mammographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K982193	ESOPHAGEAL STETHOSCOPE	1998-09-01
US	K922814	TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT	1992-09-11
US	K904397	TEC 1410	1990-11-13
BR	80553919005	COMPRESSA DE GAZE ESTÉRIL SUNSHORE	Class II
BR	80553910015	FITA MICROPOROSA SUNSHORE	Class I
BR	80553910016	ESPARADRAPO SUNSHORE	Class I

Shore Medical, Inc.

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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