Identity
- Device Name
- HUREV ECG Electrodes EUDAMED
- Model / Reference
- HR-OP37 EUDAMEDHR-OCR55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809283071088 EUDAMED
- Basic UDI-DI
- 880928307HUREVECGLT EUDAMED
- Direct Marketing DI
- 08809283071088 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
HUREV ECG Electrodes by HUREV Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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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 | 880928307HUREVECGLT | Class I | Active |
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Manufacturer
- Manufacturer
- HUREV Co., Ltd.
- EUDAMED SRN
- KR-MF-000008401
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 503c916c-d80d-4dda-a36b-0ca82ee24d4e 61 fields · synced Jun 19, 2026