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touchECG System config. Windows HD+15 Reusable
EUDAMEDClass IIa (EU MDR)
Ref KTCH3000E-ERef KTCH3000E-AE
Identity
- Device Name
- touchECG System config. Windows HD+15 Reusable EUDAMEDtouchECG System config. Windows HD+15 - Reusable AHA EUDAMED
- Model / Reference
- KTCH3000E-E EUDAMEDKTCH3000E-AE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732651456 EUDAMED08056732651449 EUDAMED
- Basic UDI-DI
- B-08056732651456 EUDAMEDB-08056732651449 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. Windows HD+15 Reusable 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-08056732651456 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (2)
- EUDAMED 8822e1df-8d1a-4eea-8149-f19006ea6a23 61 fields · synced Jul 14, 2026
- EUDAMED e75c5ee1-bf4f-4985-90f9-ce7328276a5f 61 fields · synced May 17, 2026