Identity
- Trade Name
- ISTEL ECG EUDAMED
- Device Name
- ISTEL ECG application EUDAMED
- Model / Reference
- ISTEL ECG EUDAMED8004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907581250693 EUDAMED
- Basic UDI-DI
- B-05907581250693 EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Poland 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
Istel Ecg by Diagnosis S.a. — 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-05907581250693 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Diagnosis S.a.
- EUDAMED SRN
- PL-MF-000014187
Sources (1)
- EUDAMED c09a3e60-0939-460a-bd24-27d16ecbe340 61 fields · synced Jul 10, 2026