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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
Pocket Mask, w/O2, SP w/o wipe (Black, CDN)	83004120	FDA UDI	Class II	Active
Keyring w/LFs x 25 (US) Red	46990901	FDA UDI	Class II	Active
Pocket Mask O2, SP Blue (DE FR ES IT EN)	83002110	FDA UDI	Class I	Active
V-Vac Starter kit w/out Catheter	98500020	FDA UDI	Class II	Unknown
Moore Medical CPR Mask, Barrier Dev. 73508	820046	FDA UDI	Class II	Unknown
Moore Medical CPR Mask, Barrier Dev. w/O2 73509	830046	FDA UDI	Class II	Unknown
NeoNatalie Complete Dark (US)	104-10003	FDA UDI	Class II	Active
Pocket Mask O2 HC (IE)	83001133	FDA UDI	Class II	Active
LFS 1pkg (10pcs) for UDI for Foil Pack 6361	20-09489	FDA UDI	Class II	Active
NeoBeat Charging Stand	532-20050	FDA UDI	Class II	Active
NeoNatalie Complete Light (US)	104-10004	FDA UDI	Class II	Active
Pocket Mask, PB (DE FR ES IT EN)	82002133	FDA UDI	Class I	Active
LCSU 4, 300 ml, RTCA Complete unit (US)	88006201	FDA UDI	Class II	Unknown
LCSU 4, 800 ml, RTCA Complete Unit (UK)	88005203	FDA UDI	Class II	Unknown
Pocket Mask, HC White Private Label	829932	FDA UDI	Class I	Active
NeoBeat Mini Newborn Heart Rate Meter	531-01001	FDA UDI	Class II	Active
Keyring w/LFS x 25 (US) Blue	46991101	FDA UDI	Class II	Unknown
LFS 1pkg (10pcs) for UDI for Foil Pack 6422	20-09490	FDA UDI	Class II	Active
LFS 1pcs for UDI for Foil Pack 6361	20-09485	FDA UDI	Class II	Active
LSU w/Serres Suction Bag Canister, Canadian English	78003020	FDA UDI	Class II	Active
Pocket Mask O2, SP Black Private Label	839922	FDA UDI	Class I	Active
McKesson CPR Mask, Barrier Dev. 73508	820046	FDA UDI	Class II	Unknown
Pocket Mask w/O2, SP (Camouflage IE)	83004233	FDA UDI	Class II	Unknown
Pocket Mask, HC Yellow (DE FR ES IT EN)	82002133	FDA UDI	Class I	Active
NeoNatalie Complete Dark (US)	LGH-104-10003	FDA UDI	Class II	Active
LSU w/Reusable Canister, Canadian French	78000016	FDA UDI	Class II	Unknown
Pocket Mask O2, SP Blue (EN)	83002133	FDA UDI	Class I	Active
Pocket Mask O2, SP Camo Private Label	839923	FDA UDI	Class I	Active
LSU w/Reusable Canister, Canadian English	78000020	FDA UDI	Class II	Active
LSR Preterm Cpl.w/Masks in Compact Case (EUR)	85005340	FDA UDI	Class II	Active
Pocket Mask, SP Camo Private Label	829923	FDA UDI	Class I	Active
NeoBeat Newborn Heart Rate Meter	532-01001	FDA UDI	Class II	Active
Pocket Mask w/O2, SP (Black IE)	83004133	FDA UDI	Class II	Active
NeoNatalie Resuscitator (US)	LGH-84604001	FDA UDI	Class II	Active
PM O2 w/gloves ARC stock no.329704	830006	FDA UDI	Class II	Unknown
LSR Preterm Cpl.w/Masks in Compact Case (IE)	85005333	FDA UDI	Class II	Active
Pocket Mask O2, HC White Private Label	839932	FDA UDI	Class I	Active
Pocket Mask SP w/o wipe (Black CDN)	82004120	FDA UDI	Class II	Unknown
The BAG II Resuscitator Adult w/mask #4	845141	FDA UDI	Class II	Active
NeoBeat Sys Newborn Heart Rate Meter	532-00001	FDA UDI	Class II	Active
LCSU 4, 300 ml, Complete Unit (EUR)	88006140	FDA UDI	Class II	Unknown
LCSU 4, 300 ml, RTCA Complete unit (EUR)	88006240	FDA UDI	Class II	Unknown
LCSU 4, 300 ml, Complete Unit (US)	88006101	FDA UDI	Class II	Unknown
CPRmeter 2 (Multi-bundle)	801	FDA UDI	Class II	Active
Pocket Mask, SP Black Private Label	829922	FDA UDI	Class I	Active
LSU w/Bemis Canister	78002001	FDA UDI	Class II	Active
Pocket Mask w/O2 HC SP w/o wipe (Blue CDN)	83004020	FDA UDI	Class II	Active
Pocket Mask, HC Yellow (EN)	82003133	FDA UDI	Class I	Active
Keyring 1pkg (10pcs) UDI for Foil Pack 6900	20-09500	FDA UDI	Class II	Active
Pocket Mask HC w/o wipe (CDN)	82001120	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

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Importers

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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.