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touchECG System config. HD+12 Digital Blue
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref KTCH3PBTN-SL Ref KTCH3PBTN
Identity
- Device Name
- touchECG System config. HD+12 Digital Blue EUDAMEDtouchECG System config. HD+12 Digital EUDAMED
- Model / Reference
- KTCH3PBTN-SL EUDAMEDKTCH3PBTN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732651678 EUDAMED08056732651630 EUDAMED
- Basic UDI-DI
- B-08056732651678 EUDAMEDB-08056732651630 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+12 Digital Blue by Cardioline Spa — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160746 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056732651678 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (3)
- EUDAMED b4dc0491-eb3d-452f-a307-79cd9d04ec72 61 fields · synced Jul 12, 2026
- EUDAMED cef80c43-7568-4184-9485-e4724aa3ec21 61 fields · synced May 17, 2026
- FDA 510(k) K160746 1 fields · synced May 18, 2026