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Moyo - Fetal Heart Rate Monitor (model 520)
EUDAMEDClass IIb (EU MDR)
Ref LGH-520-00090Model Moyo System Fetal Heart Rate Monitor (model 520)
Identity
- Trade Name
- Moyo - Fetal Heart Rate Monitor (model 520) EUDAMED
- Device Name
- Moyo System Fetal Heart Rate Monitor (model 520) EUDAMED
- Model / Reference
- Moyo System Fetal Heart Rate Monitor (model 520) EUDAMEDLGH-520-00090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07045432118926 EUDAMED
- Basic UDI-DI
- 0704543209972T9 EUDAMED
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Moyo is a fetal heart rate (FHR) monitor using Doppler ultrasound technology. A transabdominal belt can be used to secure the ultrasound transducer to the mother’s abdomen. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Moyo - Fetal Heart Rate Monitor (model 520) 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 | 0704543209972T9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-PR-000002650
Sources (1)
- EUDAMED 7b79509d-c668-4a43-a961-42d580f83b8a 61 fields · synced Oct 6, 2026