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Laerdal Medical Corp.

Last updated May 24, 2026

What Laerdal Medical Corp. makes

Laerdal Medical Corp. manufactures reusable and single-use cardiopulmonary resuscitation masks, manual pulmonary resuscitators, wearable neonatal heart rate meters, electric emergency airway clearance suction systems, noninvasive device battery chargers, and electronic cardiopulmonary resuscitation feedback devices.

The company's devices are classified as Class I, II, and III and are listed in the FDA 510(k) and FDA UDI registries; Laerdal Medical Corp. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Laerdal Medical Corp. manufacture?

Where is Laerdal Medical Corp. based?

Laerdal Medical Corp. is based in the United States, as stated directly in the COMPANY and COUNTRY fields and reiterated in the SUMMARY section of the provided data.

Which regulatory registries list devices from Laerdal Medical Corp.?

Devices from Laerdal Medical Corp. are listed in the FDA 510(k) and FDA UDI registries, as explicitly stated in the LISTED IN field and confirmed in the SUMMARY section of the provided data.

How are Laerdal Medical Corp.'s devices classified?

Laerdal Medical Corp.'s devices are classified as Class I, Class II, and Class III, as directly stated in the DEVICE CLASSES field and repeated in the SUMMARY section of the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (90)

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Device	Model / Reference	Registries	Class	Status
CPRmeter	801	FDA UDI	Class II	Unknown
Pocket Mask O2, HC Yellow (DE FR ES IT EN)	83003110	FDA UDI	Class I	Active
Pocket Mask O2, PB (EN)	83000133	FDA UDI	Class I	Active
LCSU 4, 300 ml, Complete Unit (UK)	88006103	FDA UDI	Class II	Unknown
LCSU4, 800 ml Complete unit (UK)	88005103	FDA UDI	Class II	Unknown
LCSU 4, 300 ml, RTCA Complete unit (UK)	88006203	FDA UDI	Class II	Unknown
LSR Paediatric Basic wo/Mask in carton (EUR) PL	86995040	FDA UDI	Class II	Unknown
LCSU4, 800 ml Complete unit (EUR)	88005140	FDA UDI	Class II	Unknown
NeoNatalie Resuscitator (US)	84604001	FDA UDI	Class II	Active
Pocket Mask O2, PB (DE FR ES IT EN)	83000110	FDA UDI	Class I	Active
Pocket Mask O2 HC w/o wipe (CDN)	83001120	FDA UDI	Class II	Unknown
PEEP 1unit for UDI for 845040	20-09502	FDA UDI	Class II	Unknown
LCSU4, RTCA 800 ml Complete unit (EUR)	88005240	FDA UDI	Class II	Unknown
V-Vac starter kit	985000	FDA UDI	Class II	Unknown
Keyring w/LFS x 25 (US) Black	46991001	FDA UDI	Class II	Active
Keyring w/LFS x 25 (US) Yellow	46990801	FDA UDI	Class II	Active
Pocket Mask w/gloves ARC stock no.329705	820012	FDA UDI	Class II	Active
Pocket Mask, SP (ARC)	820015	FDA UDI	Class II	Active
LFS 1pkg (10pcs) for UDI for Foil Pack N0918	20-09492	FDA UDI	Class II	Active
NeoBeat Mini Sys Newborn Heart Rate Meter	531-00001	FDA UDI	Class II	Active
Pocket Mask, SP Blue (EN)	82002133	FDA UDI	Class I	Active
LCSU4, 800 ml Complete unit (US)	88005101	FDA UDI	Class II	Active
Pocket Mask, PB (EN)	82000133	FDA UDI	Class I	Active
LSU w/Serres Suction Bag Canister, Canadian French	78003016	FDA UDI	Class II	Active
Pocket Mask SP w/o wipe (Blue CDN)	82004020	FDA UDI	Class II	Active
NeoNatalie Complete Light	LGH-104-10004	FDA UDI	Class II	Active
LCSU4, RTCA 800 ml Complete unit (US)	88005201	FDA UDI	Class II	Active
Pocket Mask O2, HC Yellow (EN)	83003133	FDA UDI	Class I	Active
LFS 1pkg (10pcs) for UDI for Foil Pack 6503	20-09491	FDA UDI	Class II	Unknown
Pocket Mask, SP, PL	829940	FDA UDI	Class II	Active
McKesson CPR Mask, Barrier Dev. w/O2 73509	830046	FDA UDI	Class II	Unknown
Heartstart 911	K954609	FDA 510(k)	Class III	Active
Heartstart 3000	K896919	FDA 510(k)	Class III	Active
Modulaide Emerg. Cardiac Life Supp. Kt	K822356	FDA 510(k)	Class II	Active
Lsu 2000 Portable Suction Unit	K950698	FDA 510(k)	Class II	Active
Trachlight Stylet And Tracheal Lightwand	K962361	FDA 510(k)	Class I	Active
Resusci Inflate-A-Shield Cpr Barrier	K001742	FDA 510(k)	Class II	Active
Laerdal(tm) Pocket Mask, Modification	K933048	FDA 510(k)	Class I	Active
Trachlight Stylet & Tracheal Lightwand (original Application Name: Stylett & Tracheal Lightwand)	K954771	FDA 510(k)	Class I	Active
Resusci Patient Face Shield	K880450	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 8 recall records for Laerdal Medical Corp., with the earliest initiated on 2003-12-23 and the most recent on 2026-01-13. The statuses of these recalls include open, classified, and terminated. The reasons given for the recalls include potential dislodgement of the Flap Valve component rendering the resuscitator inoperative, electromagnetic noise emissions exceeding RTCA DO-160G limits for certain units, refusal of importation due to lack of necessary FDA approvals for LCSU 4 suction units and canisters, wire breakage in adapter cables causing inability to operate the defibrillator, and potential damage to electronic components affecting the On/Off functionality of the LCSU 4.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jan 13, 2026	Z-1341-2026	—	open, classified	units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
Aug 31, 2017	Z-0973-2018	—	terminated	A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.
Jan 8, 2017	Z-1873-2017	—	terminated	The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.
Apr 29, 2005	Z-0805-05	—	terminated	Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
Dec 23, 2003	Z-0518-04	—	terminated	Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
Dec 23, 2003	Z-0519-04	—	terminated	Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
Dec 23, 2003	Z-0520-04	—	terminated	Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
Dec 23, 2003	Z-0517-04	—	terminated	Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.