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Home›Norway›LAERDAL MEDICAL A/S

LAERDAL MEDICAL A/S

Norway · Stavanger Rogaland
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 7 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
17listed device types
Class I 9Class II 8Class III 0
plus 31 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
13active device licences
Class II 11Class III 2
22 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
6device registrations
CLASS B 6
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
26active ARTG entries
Class I 10IIa 9IIb 7
HKHong KongMDACS
3valid listings
Class II 3
ILIsraelAMAR
11registrations
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 States31 registration records, 20 510(k), 0 PMA, 2 excluded
Canada13 confirmed, 0 excluded
Manufacturer names merged into this page: LAERDAL MEDICAL (SUZHOU) CO., LTD. · LAERDAL MEDICAL A/S · Laerdal Medical AS, Stavanger Manufacturing · LAERDAL MEDICAL AS · LAERDAL MEDICAL CANADA LTD.
Same-named companies — This database also contains companies with near-identical names: Laerdal Medical Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Norway
City
Stavanger Rogaland

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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 17
Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Attachment, Breathing, Positive End Expiratory Pressure 1Aid, Cardiopulmonary Resuscitation 1Valve, Non-Rebreathing 1Ventilator, Emergency, Manual (Resuscitator) 1Pump, Portable, Aspiration (Manual Or Powered) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251631The BAG manual resuscitator and accessories2025-11-24
USK232111NeoBeat, NeoBeat Mini2024-06-25
USK183348Reusable Silicone Cover CPRmeter 22018-12-17
CA19301TRACHLIGHT STYLET AND TRACHEAL LIGHT WANDClass II
CA21437HEARTSTART 4000 DEFIBRILLATORClass III
CA26896LAERDAL HEARTSTART FR2Class III

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