Identity
- Device Name
- HeartView EUDAMED
- Model / Reference
- 12L EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HeartView-12LY5 EUDAMED
- Basic UDI-DI
- B-HeartView-12LY5 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-12LY5 | 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 (1)
- EUDAMED 1432c35a-0eb2-425e-be5f-df248b6dd7f7 61 fields · synced Jun 17, 2026