Identity
- Device Name
- HRS EUDAMED
- Model / Reference
- - EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RHSFJ EUDAMED
- Basic UDI-DI
- B-RHSFJ EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Hrs 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-RHSFJ | 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 d2d2d70b-8cf3-4d05-875f-0899a16561ad 61 fields · synced Jun 19, 2026