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Repeatable ECG electrodes
EUDAMEDClass I (EU MDR)
Ref ZCXCS003Model ZCXCS001、ZCXES001、ZCXCS002、ZCXES002、ZCXCS003、ZCXES003、ZCXCD004、ZCXED004、ZCXCD005、ZCXED005、ZCXCS012、ZCXCS013、ZCXCS014、ZCXCS015、ZCXCS016、ZCXES012、ZCXES013、ZCXES014、ZCXES015、etc
Identity
- Device Name
- Repeatable ECG electrodes EUDAMED
- Model / Reference
- ZCXCS001、ZCXES001、ZCXCS002、ZCXES002、ZCXCS003、ZCXES003、ZCXCD004、ZCXED004、ZCXCD005、ZCXED005、ZCXCS012、ZCXCS013、ZCXCS014、ZCXCS015、ZCXCS016、ZCXES012、ZCXES013、ZCXES014、ZCXES015、etc EUDAMEDZCXCS003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976774220002 EUDAMED
- Basic UDI-DI
- 697677422REE01QP EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Repeatable ECG electrodes by Shenzhen Z-Rui Century Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
- ECG leadwire — Shenzhen City Teveik Technology Co., Ltd. · Class I
- Elektrody EKG — SORIMEX sp. z o.o. · Class I
- ECG — Zoll Medical Corporation · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
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 | 697677422REE01QP | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Z-Rui Century Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000042985
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d8e320b8-3c22-4dcc-b260-e2565dc85a68 61 fields · synced Jun 18, 2026