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NeoBeat Sys (LGH) Newborn Heart Rate Meter

EUDAMED

Class IIb (EU MDR)

Ref LGH-532-00090Model NeoBeat SystemRef LGH-532-00033Model NeoBeat (IE) (LGH), Newborn Heart Rate Meter

by Laerdal Medical AS

Identity

Trade Name
NeoBeat Sys (LGH) Newborn Heart Rate Meter EUDAMED
NeoBeat EUDAMED
Device Name
NeoBeat System EUDAMED
NeoBeat EUDAMED
Model / Reference
NeoBeat System EUDAMED
LGH-532-00090 EUDAMED
NeoBeat (IE) (LGH), Newborn Heart Rate Meter EUDAMED
LGH-532-00033 EUDAMED

Identifiers

Primary DI / UDI-DI
07045432120240 EUDAMED
07045432098686 EUDAMED
Basic UDI-DI
0704543209964TA EUDAMED
B-07045432098686 EUDAMED
EMDN Code
Z12080480,Z12080499 EUDAMED
Z12080103 FOETAL HEARTBEAT DETECTORS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Market of Registration
Norway EUDAMED
Medical Purpose
NeoBeat Newborn Heart Rate Meter is indicated to measure the heart rate in newborns. EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

NeoBeat Sys (LGH) Newborn Heart Rate Meter by Laerdal Medical AS — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Laerdal Medical AS
EUDAMED SRN
NO-PR-000002650

Sources (2)

  • EUDAMED b0f2c39b-980c-4245-8606-2a820df1e796 61 fields · synced Oct 6, 2026
  • EUDAMED 0b52da40-ab62-4fe6-9677-08d80eed2313 61 fields · synced May 19, 2026