Identity
- Trade Name
- MEDPEX EUDAMED
- Device Name
- ECG ELECTRODE EUDAMED
- Model / Reference
- B4346 EUDAMEDMP43 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974081784637 EUDAMED
- Basic UDI-DI
- 697408178B43469G EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I 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: Electrocardiographic electrode, single-use
Medpex by Bss Medical Supply Co., Limited — 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 | 697408178B43469G | Class I | Active |
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Manufacturer
- Manufacturer
- Bss Medical Supply Co., Limited
- EUDAMED SRN
- CN-MF-000033301
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 67d27145-08ac-42f3-aa5a-38166bac1649 61 fields · synced Jun 19, 2026