Home›China›LAERDAL MEDICAL (SUZHOU) CO., LTD.

LAERDAL MEDICAL (SUZHOU) CO., LTD.

China · Suzhou Jiangsu Province

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, South Korea — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 9Class II 7Class III 0

plus 28 registration records and 20 510(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

9active device licences

Class II 7Class III 2

18 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

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 States28 registration records, 20 510(k), 0 PMA, 3 excluded

Canada9 confirmed, 1 excluded

Manufacturer names merged into this page: LAERDAL MEDICAL (SUZHOU) CO., LTD. · LAERDAL MEDICAL A/S · LAERDAL MEDICAL AS

FDA 510(k) clearances by year

11982

11984

11986

11988

11990

11993

11995

31996

11999

12000

12003

12012

22015

22018

12024

12025

FDA listed device types

showing 8 of 16

Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Attachment, Breathing, Positive End Expiratory Pressure 1Aid, Cardiopulmonary Resuscitation 1Valve, Non-Rebreathing 1Ventilator, Emergency, Manual (Resuscitator) 1Pump, Portable, Aspiration (Manual Or Powered) 1Stretcher, Hand-Carried 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251631	The BAG manual resuscitator and accessories	2025-11-24
US	K232111	NeoBeat, NeoBeat Mini	2024-06-25
US	K183348	Reusable Silicone Cover CPRmeter 2	2018-12-17
CA	19301	TRACHLIGHT STYLET AND TRACHEAL LIGHT WAND	Class II
CA	21437	HEARTSTART 4000 DEFIBRILLATOR	Class III
CA	26896	LAERDAL HEARTSTART FR2	Class III

LAERDAL MEDICAL (SUZHOU) CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies