Identity
- Trade Name
- TELECTRODE EUDAMED
- Device Name
- ECG Electrodes EUDAMED
- Model / Reference
- T832 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809083946555 EUDAMED
- Basic UDI-DI
- 880908394010KC EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES 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
Telectrode by Bio Protech Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880908394010KC | Class I | Unknown |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- EUDAMED SRN
- KR-MF-000012687
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED 5574da2e-b509-478f-a1a5-86320e88916b 61 fields · synced May 23, 2026