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touchECG System config. Digital Premium Blue
EUDAMEDClass IIa (EU MDR)
Ref KTCH3PCS0-SL
Identity
- Device Name
- touchECG System config. Digital Premium Blue EUDAMED
- Model / Reference
- KTCH3PCS0-SL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732651722 EUDAMED
- Basic UDI-DI
- B-08056732651722 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. Digital Premium Blue 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-08056732651722 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (1)
- EUDAMED c92a885e-6c65-4c73-ac44-b6960a33d94f 61 fields · synced Jul 19, 2026