Identity
- Device Name
- HeartView EUDAMED
- Model / Reference
- P12/8 Mobile EUDAMED12i EUDAMEDP12/8i EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HeartView-P12/8MobileMS EUDAMEDD-HeartView-12iZM EUDAMEDD-HeartView-P12/8i26 EUDAMED
- Basic UDI-DI
- B-HeartView-P12/8MobileMS EUDAMEDB-HeartView-12iZM EUDAMEDB-HeartView-P12/8i26 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HeartView by Aerotel Medical Systems (1998) Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-HeartView-P12/8MobileMS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aerotel Medical Systems (1998) Ltd.
- EUDAMED SRN
- IL-MF-000038449
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (3)
- EUDAMED bf99f2ea-90b6-4427-9411-ee0985ddba05 61 fields · synced Sep 18, 2026
- EUDAMED c1a5b825-cf73-4e59-a890-f86185df52f9 61 fields · synced May 17, 2026
- EUDAMED e5edf0fe-2291-44b6-9e87-a1bd47572e84 61 fields · synced May 18, 2026