Identity
- Device Name
- touchECG System Config. HD+ Dongle EUDAMED
- Model / Reference
- KTCH30000-MG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732651401 EUDAMED
- Basic UDI-DI
- B-08056732651401 EUDAMED
- EMDN Code
- Z12050302 ADVANCED DIAGNOSIS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
touchECG System Config. HD+ Dongle 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-08056732651401 | 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 5458a9ef-8c08-465f-8cf5-0d7af4b58134 61 fields · synced Jul 10, 2026