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NeoBeat Mini Sys (Nordic) Newborn Heart Rate Meter

by Laerdal Medical AS

Ref 531-00000Model NeoBeat System

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0704543209964TA Basic UDI-DI 07045432112337UDI-DIDate25 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
NeoBeat System
Model / Reference
NeoBeat System, 531-00000
Primary DI / UDI-DI
07045432112337
Basic UDI-DI
0704543209964TA
EMDN Code
Z12080480, Z12080499
Device Class
Class IIb
Medical Purpose
NeoBeat Newborn Heart Rate Meter is indicated to measure the heart rate in newborns.

Manufacturer details

EUDAMED SRN
NO-PR-000002650

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Properties

Other properties (1)

  • Sterile: No