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BIO-MED DEVICES, INC.

USA · Guilford

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

6listed device types

Class I 2Class II 4Class III 0

plus 10 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

3active device licences

Class II 3

6 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IIa 1IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 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 States10 registration records, 20 510(k), 0 PMA, 340 excluded

Brazil1 confirmed, 132 excluded

Saudi Arabia0 confirmed, 34 excluded

Canada3 confirmed, 48 excluded

Manufacturer names merged into this page: BIO-MED DEVICES, INC. · BIO-MED DEVICES, INC

FDA 510(k) clearances by year

51980

21981

11982

21983

31987

11988

21990

11995

12018

12022

12025

FDA listed device types

Analyzer, Gas, Oxygen, Gaseous-Phase 1Mixer, Breathing Gases, Anesthesia Inhalation 1Ventilator, Continuous, Facility Use 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Set, Tubing And Support, Ventilator (W Harness) 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251245	OxyMinder Pro (10310)	2025-08-11
US	K213948	OxyMinder	2022-03-17
US	K173973	TV-100	2018-07-20
BR	80102519183	Blender Misturador de Ar/Oxigênio	Class II
CA	7759	VENTILATION MONITOR	Class II
CA	7761	M-2 OXYGEN TEMPERATURE MONITOR	Class II
CA	7769	ARID AIR COMPRESSOR	Class II

BIO-MED DEVICES, 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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