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ECG Electrode
EUDAMEDClass I (EU MDR)
Ref EC012A/BModel EC012, EC012-A, EC012A/A-HP, EC012A/B, EC012A/B-G, EC012A-HP, EC012B, EC012B/I, EC012B/A, EC012B/A-HP, EC012B-HP, EC012C, EC012C/A, EC012A-HP, EC012B-HP, EC012C-HP, etc
Identity
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- EC012, EC012-A, EC012A/A-HP, EC012A/B, EC012A/B-G, EC012A-HP, EC012B, EC012B/I, EC012B/A, EC012B/A-HP, EC012B-HP, EC012C, EC012C/A, EC012A-HP, EC012B-HP, EC012C-HP, etc EUDAMEDEC012A/B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977543563603 EUDAMED
- Basic UDI-DI
- 697754356EE001GQ 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
ECG Electrode by Hunan Greatmade Medical Tech Limited — 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 | 697754356EE001GQ | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Greatmade Medical Tech Limited
- EUDAMED SRN
- CN-MF-000042754
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED db954643-9004-4e27-9911-37899ee2e4d0 61 fields · synced Jul 14, 2026