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INTERNATIONAL BIOMEDICAL, LTD.

USA · Austin

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Australia, Israel, Russia — 5 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 5Class II 13Class III 0

plus 26 registration records and 17 510(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

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 7IIa 3IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 1Class 2b 2

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 States26 registration records, 17 510(k), 0 PMA, 332 excluded

Brazil0 confirmed, 62 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada1 confirmed, 53 excluded

Manufacturer names merged into this page: INTERNATIONAL BIOMEDICAL, LTD.

FDA 510(k) clearances by year

11996

12002

12003

12008

12009

42011

12014

12016

12018

12019

12020

32022

FDA listed device types

showing 8 of 18

Incubator, Neonatal Transport 1Electrode, Electrocardiograph 1Apparatus, Nitric Oxide Delivery 1Pump, Infusion, Analytical Sampling 1Analyzer, Nitric Oxide 1Apparatus, Nitric Oxide, Backup Delivery 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Ventilator, Continuous, Facility Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221154	Infant Heel WarmerTM; Heel Snuggler®	2022-10-07
US	K221653	InfaTherm Disposable Infant Warming Mattress	2022-10-06
US	K220742	NxtGen Infant Transport Incubator	2022-07-15
CA	73984	RADIATION ATTENUATING SURGICAL GLOVE	Class II

INTERNATIONAL BIOMEDICAL, 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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