NeoBeat Sys Newborn Heart Rate Meter

FDA UDIEUDAMED

Class II (US FDA UDI)

by Laerdal Medical Corp.

Identity

Trade Name: NeoBeat Sys Newborn Heart Rate Meter FDA UDI
Generic Name: Wearable neonatal heart rate meter FDA UDI
Device Name: NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display. FDA UDI
Model / Reference: 532-00001 FDA UDI
Description: NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display. FDA UDI

Identifiers

Catalog Number: 532-00001 FDA UDI
Primary DI / UDI-DI: 07045432112511 FDA UDI
510(k) Number: K232111 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: Wearable neonatal heart rate meter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Wearable neonatal heart rate meter

NeoBeat Sys Newborn Heart Rate Meter by Laerdal Medical Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Wearable neonatal heart rate meter.

NeoBeat Mini Newborn Heart Rate Meter — Laerdal Medical Corp. · Class II
NeoBeat Mini Sys Newborn Heart Rate Meter — Laerdal Medical Corp. · Class II
NeoBeat Newborn Heart Rate Meter — Laerdal Medical Corp. · Class II

Cleared under the same submission

K232111 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Laerdal Medical Corp.

Sources (2)

FDA UDI 9d4f2ee2-e051-452f-b6a6-9a6ca20852c8 36 fields · synced Jun 17, 2026
EUDAMED 1 fields · synced Jun 2, 2026