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touchECG System config. HD+15 Digital AHA
EUDAMEDClass IIa (EU MDR)
Ref KTCH3PBTE-ARef KTCH3PBTE-AERef KTCH3PBTE
Identity
- Device Name
- touchECG System config. HD+15 Digital AHA EUDAMEDtouchECG System config. HD+15 Digital AHA Reus. EUDAMEDtouchECG System config. HD+15 Digital EUDAMED
- Model / Reference
- KTCH3PBTE-A EUDAMEDKTCH3PBTE-AE EUDAMEDKTCH3PBTE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732651593 EUDAMED08056732651609 EUDAMED08056732651586 EUDAMED
- Basic UDI-DI
- B-08056732651593 EUDAMEDB-08056732651609 EUDAMEDB-08056732651586 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+15 Digital AHA 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-08056732651593 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (3)
- EUDAMED 686713b1-d38c-45de-8a23-d18f6398a68e 61 fields · synced Jul 10, 2026
- EUDAMED ebd8dfd4-a039-4a0e-ae91-0fdb8d8f5a7e 61 fields · synced May 17, 2026
- EUDAMED 0748295d-7758-4e5b-924d-1c984e13738b 61 fields · synced May 17, 2026