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Coast Medical, Inc.

USA · Orange

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

53listed device types

Class I 43Class II 7Class III 1unclassified 2

plus 55 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

2active device licences

Class II 2

7 including historic records

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 States55 registration records, 13 510(k), 0 PMA, 17 excluded

Brazil4 confirmed, 0 excluded

Canada2 confirmed, 3 excluded

Manufacturer names merged into this page: NORTH COAST MEDICAL, INC. · ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC. · NORTH COAST MEDICAL INC

FDA 510(k) clearances by year

11990

21992

21993

51994 · K944729

21995 · K952243

12005 · K052019

FDA listed device types

showing 8 of 53

Unit, Wrist, External Limb Component, Mechanical 1Splint, Hand, And Components 1Fentanyl And Other Opioid Protection Glove 1Insoles, Medical 1Pill Crusher/Cutter 1Exerciser, Non-Measuring 1Adaptor, Recreational 1Utensil, Homemaking 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K052019	NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE	2005-11-04
US	K952243	EXTENSION SET/I.V. SET	1995-07-26
US	K930929	ESOPHAGEAL STETHOSCOPE	1995-03-17
BR	10352830003	VENTOSA PARA CICATRIZ	Class I
BR	10352830004	MINI VIBRADOR NORTH COAST	Class I
BR	10352830006	BANDAGEM ELASTICA DEMA	Class I
CA	14376	COMFORT EASE ELECTRODE	Class II
CA	14377	JELTRODE ELECTRODE	Class II

Coast 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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