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NeoBeat Mini Newborn Heart Rate Meter

FDA UDI

Class II (US FDA UDI)

by Laerdal Medical Corp.

Identity

Trade Name
NeoBeat Mini 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
531-01001 FDA UDI
Description
NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display. FDA UDI

Identifiers

Catalog Number
531-01001 FDA UDI
Primary DI / UDI-DI
07045432118308 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wearable neonatal heart rate meter

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

Similar devices

Also classified as Wearable neonatal heart rate meter.

Cleared under the same submission

K232111 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laerdal Medical Corp.

Sources (1)

  • FDA UDI 223fdb04-10f4-4f59-b759-1a0be1d9a092 36 fields · synced May 30, 2026