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Electrode Pads
EUDAMEDClass I (EU MDR)
Ref Rectangular50×50Model Rectangular Circular Oval Hand shape Other
Identity
- Device Name
- Electrode Pads EUDAMED
- Model / Reference
- Rectangular Circular Oval Hand shape Other EUDAMEDRectangular50×50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976378040297 EUDAMED
- Basic UDI-DI
- 697637804EP001HZ EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE 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: Open-surgery electrosurgical electrode, monopolar, single-use
Electrode Pads by Dong Guan Ou Kang Electronics Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical electrode, monopolar, 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 | 697637804EP001HZ | Class I | Active |
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Manufacturer
- Manufacturer
- Dong Guan Ou Kang Electronics Co., Ltd
- EUDAMED SRN
- CN-MF-000037291
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ca4999b5-f10f-4f3f-8584-4e0671eaad2e 61 fields · synced Jun 18, 2026