Identity
- Trade Name
- PADSY ECG 4.6 EUDAMEDPADSY ECG EUDAMED
- Device Name
- PADSY ECG EUDAMEDPADSY ECG 4.5 EUDAMED
- Model / Reference
- AAG138103 EUDAMEDAAG137110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250403735238 EUDAMED04250403735221 EUDAMED
- Basic UDI-DI
- 42504037AAG138000-00D4 EUDAMEDB-04250403735221 EUDAMED
- Direct Marketing DI
- 04250403735238 EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED-1192 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Padsy Ecg 4.6 by Medset Medizintechnik GmbH — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 42504037AAG138000-00D4 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 42504037AAG138000-00D4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medset Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000016442
Sources (2)
- EUDAMED 8bb7dcfb-b756-4b1d-bb7d-3f3cd0ac90f6 61 fields · synced Jul 11, 2026
- EUDAMED b708ee91-6590-478d-8dd3-53993162e5a1 61 fields · synced May 17, 2026