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Disposable ECG Electrodes
EUDAMEDClass I (EU MDR)
Ref TF12Model TF01,TF02,TF03,TF04,TF05,TF06,TF07,TF08,TF09,TF10,TF11,TF12,TF13,TF14,TF15,TF16, TN01,TN02,TN03,TN04,TN05,TN06,TN07,TN08,TN08,TN09, etc
Identity
- Device Name
- Disposable ECG Electrodes EUDAMED
- Model / Reference
- TF01,TF02,TF03,TF04,TF05,TF06,TF07,TF08,TF09,TF10,TF11,TF12,TF13,TF14,TF15,TF16, TN01,TN02,TN03,TN04,TN05,TN06,TN07,TN08,TN08,TN09, etc EUDAMEDTF12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978812870118 EUDAMED
- Basic UDI-DI
- 697881287ECGELECTRODESQ3 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 Electrodes by Shanghai Heramed Tech 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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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 | 697881287ECGELECTRODESQ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Heramed Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048531
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED dc684496-2779-4d10-bc09-4d7b1def2be2 61 fields · synced Jun 19, 2026