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Disposable ECG Electrode
EUDAMEDClass I (EU MDR)
Ref GC-0026Model GC-0017、GC-0018、GC-0019、GC-0020、GC-0021、GC-0024、GC-0025、GC-0026、GC-0027、GC-0028、GC-0029、GC-0030、GC-0035、GC-0040、GC-0042、GC-0043、GC-0045、GC-0050、GC-0055、GC-0047 etc
Identity
- Device Name
- Disposable ECG Electrode EUDAMED
- Model / Reference
- GC-0017、GC-0018、GC-0019、GC-0020、GC-0021、GC-0024、GC-0025、GC-0026、GC-0027、GC-0028、GC-0029、GC-0030、GC-0035、GC-0040、GC-0042、GC-0043、GC-0045、GC-0050、GC-0055、GC-0047 etc EUDAMEDGC-0026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977563441073 EUDAMED
- Basic UDI-DI
- 697756344GCDECGEWL 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
Disposable ECG Electrode by Dongguan Goceng Medical Supplies 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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- 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 | 697756344GCDECGEWL | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Goceng Medical Supplies Co., Ltd
- EUDAMED SRN
- CN-MF-000042512
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f8e68dcf-7c4a-4908-9ec1-39e882b18667 61 fields · synced Jun 18, 2026