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External ECG sensor for ABPMpro
EUDAMEDClass IIa (EU MDR)
Ref ABP520Model ECG sensor
Identity
- Trade Name
- External ECG sensor for ABPMpro EUDAMED
- Model / Reference
- ECG sensor EUDAMEDABP520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413402991 EUDAMED
- Basic UDI-DI
- 42504134EKG-S7W EUDAMED
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
External ECG sensor for ABPMpro by SOMNOmedics AG — Class IIa — 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 | 42504134EKG-S7W | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED 7da1c50f-9b4a-4b25-9cc0-af28e7cdea4c 61 fields · synced Jun 18, 2026