Identity
- Device Name
- HD+12 R2 EUDAMED
- Model / Reference
- 81018231 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732650794 EUDAMED
- Basic UDI-DI
- B-08056732650794 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hd+12 R2 by Cardioline Spa — 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-08056732650794 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (1)
- EUDAMED ef654427-43d8-49a7-b8e1-3005f2a39afd 61 fields · synced Jul 14, 2026