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CustoMED , Ltd.

USA · Fajardo

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 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

111listed device types

Class I 71Class II 39Class III 0unclassified 1

plus 162 registration records and 37 510(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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 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 States162 registration records, 37 510(k), 0 PMA

Manufacturer names merged into this page: CUSTOMED, INC.

FDA 510(k) clearances by year

161990

21991

91993

11994

21995

41996

11997

11998

12026

FDA listed device types

showing 8 of 111

Cystoscope And Accessories, Flexible/Rigid 1Nebulizer (Direct Patient Interface) 1Bed, Ac-Powered Adjustable Hospital 1Mask, Surgical 1Catheter, Intravascular, Diagnostic 1Probe, Thermodilution 1General Surgery Tray 1Catheter, Retention Type, Balloon 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260116	CustoMED Viewer	2026-06-03
US	K974647	FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633	1998-01-05
US	K971920	GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)	1997-12-04

CustoMED , Ltd.

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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