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BREAS MEDICAL, INC.

Sweden · Molnlycke

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, 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

14listed device types

Class I 4Class II 10Class III 0

plus 26 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 4

14 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

14device registrations

CLASS B 5CLASS C 9

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

IIa 5IIb 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 2Class 2b 3

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, 16 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: BREAS MEDICAL AB · BREAS MEDICAL, INC. · Breas Medical Ltd

FDA 510(k) clearances by year

52006

12007

12008

12009

12013

12016

12021

22024

32025

FDA listed device types

showing 8 of 14

Ventilator, Non-Continuous (Respirator) 1Accessory To Continuous Ventilator (Respirator) 1Continuous, Ventilator, Home Use 1Ventilator, Continuous, Non-Life-Supporting 1Sv70 Ventilator 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Ventilator, Continuous, Facility Use 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242485	EveryWare	2025-05-20
US	K242438	Clearo	2025-05-16
US	K233452	Vivo 45 LS	2025-01-13
BR	80117589095	Vivo 3	Class II
BR	80117589096	Vivo Bi-level CPAP	Class II
CA	62549	BREAS HUMIDIFIER HA50	Class II
CA	62598	BREAS CPAP PV 10	Class II
CA	62653	BREAS PV10I	Class II