Identity
- Trade Name
- ECG Electrodes EUDAMED
- Device Name
- ECG Electrodes EUDAMED
- Model / Reference
- YD55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975379740052 EUDAMED06975379741004 EUDAMED
- Basic UDI-DI
- 697537974YD55UB EUDAMED
- Direct Marketing DI
- 06975379740052 EUDAMED06975379741004 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Open-surgery electrosurgical electrode, monopolar, single-use
ECG Electrodes by Yancheng Tianrun Medical Instrument Factory — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697537974YD55UB | Class I | Active |
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Manufacturer
- Manufacturer
- Yancheng Tianrun Medical Instrument Factory
- EUDAMED SRN
- CN-MF-000021153
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 155c1a67-e88d-4da5-ad85-ba81af4775f6 61 fields · synced Oct 5, 2026
- EUDAMED a332cdb1-0b5b-4d05-ac35-a1ce25d79c40 61 fields · synced May 17, 2026