Identity
- Trade Name
- touchECG Windows FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- touchECG – for Windows EUDAMEDSoftware that implements a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function. FDA UDI
- Model / Reference
- 81019579 EUDAMEDtouchECG Windows FDA UDI
- Description
- Software that implements a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function. FDA UDI
Identifiers
- Catalog Number
- 81019579 FDA UDI
- Primary DI / UDI-DI
- 08056732652903 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08056732652903 EUDAMED
- 510(k) Number
- K160746 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050302 ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
touchECG – for Windows by Cardioline Spa — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08056732652903 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (2)
- EUDAMED c6831e37-1344-4b6a-a5cb-8c44fdb2496e 61 fields · synced Jul 9, 2026
- FDA UDI 6f1af4b6-36e5-43b0-ae6b-253b6dee0c9f 36 fields · synced May 30, 2026