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NeoBeat Mini Sys (LGH) Newborn Heart Rate Meter
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref LGH-531-00090Model NeoBeat System
Identity
- Trade Name
- NeoBeat Mini Sys (LGH) Newborn Heart Rate Meter EUDAMED
- Device Name
- NeoBeat System EUDAMED
- Model / Reference
- NeoBeat System EUDAMEDLGH-531-00090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045432118933 EUDAMED
- Basic UDI-DI
- 0704543209964TA EUDAMED
- EMDN Code
- Z12080480,Z12080499 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- NeoBeat Newborn Heart Rate Meter is indicated to measure the heart rate in newborns. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
NeoBeat Mini Sys (LGH) Newborn Heart Rate Meter by Laerdal Medical AS — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232111 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0704543209964TA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-PR-000002650
Sources (2)
- EUDAMED 27145b0a-8e44-4b60-8aaa-4089c24649c1 61 fields · synced Jun 18, 2026
- FDA 510(k) K232111 1 fields · synced May 18, 2026