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HUREV ECG Electrodes
EUDAMEDClass I (EU MDR)
Ref HR-OCR42Model HR-OP37Ref HR-OP42Ref HR-TE2032Ref HR-OC37Ref HR-OPR42Ref HR-OC42Ref HR-OPR55Ref HR-OP55Ref HR-OCR37
Identity
- Device Name
- HUREV ECG Electrodes EUDAMED
- Model / Reference
- HR-OP37 EUDAMEDHR-OCR42 EUDAMEDHR-OP42 EUDAMEDHR-TE2032 EUDAMEDHR-OC37 EUDAMEDHR-OPR42 EUDAMEDHR-OC42 EUDAMEDHR-OPR55 EUDAMEDHR-OP55 EUDAMEDHR-OCR37 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809283071491 EUDAMED08809283071033 EUDAMED08809283072436 EUDAMED08809283071026 EUDAMED08809283071057 EUDAMED08809283071460 EUDAMED08809283071064 EUDAMED08809283071477 EUDAMED08809283071040 EUDAMED08809283071484 EUDAMED
- Basic UDI-DI
- 880928307HUREVECGLT EUDAMED
- Direct Marketing DI
- 08809283071491 EUDAMED08809283071033 EUDAMED08809283072436 EUDAMED08809283071026 EUDAMED08809283071057 EUDAMED08809283071460 EUDAMED08809283071064 EUDAMED08809283071477 EUDAMED08809283071040 EUDAMED08809283071484 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 (10)
- EUDAMED de64e1bc-ac99-4901-9cfe-f6d9190facdf 61 fields · synced Aug 3, 2026
- EUDAMED e0900740-f156-4583-a7e9-bfde4c211dcb 61 fields · synced May 16, 2026
- EUDAMED 7419b069-2a59-4dbf-8d34-1f45e089ec7e 61 fields · synced May 17, 2026
- EUDAMED 2e30f397-a39a-4aea-bf86-a9fb3982c168 61 fields · synced May 17, 2026
- EUDAMED 7423cac1-89c0-4693-bf99-d4f18f4f331a 61 fields · synced May 17, 2026
- EUDAMED eebae69e-7410-4e2a-a3a2-5ca7c1dc200e 61 fields · synced May 17, 2026
- EUDAMED ae1010e0-d733-42c3-880d-22d8eace7122 61 fields · synced May 17, 2026
- EUDAMED 428b90c3-bdb8-450b-80bd-7992eb1731d1 61 fields · synced May 18, 2026
- EUDAMED be47b8e3-c5b8-4dc0-90cb-10e0bba29c93 61 fields · synced May 18, 2026
- EUDAMED 08c2823a-db9c-4745-b6a3-d9b19bcb74d4 61 fields · synced May 18, 2026