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touchECG System config. Digital Premium HD+12 AHA
EUDAMEDClass IIa (EU MDR)
Ref KTCH3PCSN-A Ref KTCH3PBTN-A Ref KTCH3PCSN Ref KTCH3PCT0Ref KTCH3PCS0
Identity
- Device Name
- touchECG System config. Digital Premium HD+12 AHA EUDAMEDtouchECG System config. HD+12 Digital AHA EUDAMEDtouchECG System config. Digital Premium HD+12 EUDAMEDtouchECG System config. Digital EUDAMEDtouchECG System config. Digital Premium EUDAMED
- Model / Reference
- KTCH3PCSN-A EUDAMEDKTCH3PBTN-A EUDAMEDKTCH3PCSN EUDAMEDKTCH3PCT0 EUDAMEDKTCH3PCS0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732651784 EUDAMED08056732651647 EUDAMED08056732651777 EUDAMED08056732653832 EUDAMED08056732651708 EUDAMED
- Basic UDI-DI
- B-08056732651784 EUDAMEDB-08056732651647 EUDAMEDB-08056732651777 EUDAMEDB-08056732653832 EUDAMEDB-08056732651708 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 HD+12 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-08056732651784 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (5)
- EUDAMED a26b1212-8eb0-4b05-8613-fe1ae664d58e 61 fields · synced Jul 22, 2026
- EUDAMED 30bb73fe-9eab-4f04-9c6b-7229dc73d5bf 61 fields · synced May 18, 2026
- EUDAMED 023f097c-7cf3-4238-b3aa-b7ea5bff683e 61 fields · synced May 18, 2026
- EUDAMED 9a2f7d8e-bf25-4aa7-9979-faa8fd300bb0 61 fields · synced May 19, 2026
- EUDAMED c60de7e3-0a74-4bec-9fe8-1180b0c68f1f 61 fields · synced May 19, 2026