← Back to catalogue
NeoBeat Sys (Nord) Newborn Heart Rate Meter
EUDAMEDClass IIb (EU MDR)
Ref 532-00000Model NeoBeat System
Identity
- Trade Name
- NeoBeat Sys (Nord) Newborn Heart Rate Meter EUDAMED
- Device Name
- NeoBeat System EUDAMED
- Model / Reference
- NeoBeat System EUDAMED532-00000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045432100570 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 Sys (Nord) Newborn Heart Rate Meter by Laerdal Medical AS — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0704543209964TA | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-PR-000002650
Sources (1)
- EUDAMED 084eb674-7d9a-4104-8122-1a0637ff4398 61 fields · synced Oct 6, 2026