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Disposable ECG Electrodes
EUDAMEDClass I (EU MDR)
Ref MK10017Model MK30a MK32 MK33a MK33b MK33c MK33d MK33e MK33f MK33g MK33h MK33n MK33o MK33p MK33q MK10017 MW10018 MK10019 MK10020 MK10021 MK10022
Identity
- Device Name
- Disposable ECG Electrodes EUDAMED
- Model / Reference
- MK30a MK32 MK33a MK33b MK33c MK33d MK33e MK33f MK33g MK33h MK33n MK33o MK33p MK33q MK10017 MW10018 MK10019 MK10020 MK10021 MK10022 EUDAMEDMK10017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975883471060 EUDAMED
- Basic UDI-DI
- 697588347ECGElectrodesF5 EUDAMED
- EMDN Code
- K0201010301,K0201010302 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
Disposable ECG Electrodes by Hospital & Homecare Medical Device Co., Ltd. China — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697588347ECGElectrodesF5 | Class I | Active |
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Manufacturer
- Manufacturer
- Hospital & Homecare Medical Device Co., Ltd. China
- EUDAMED SRN
- CN-MF-000032014
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d4b2fc08-1e97-488d-a85f-47bf1ba24f8f 61 fields · synced Oct 6, 2026