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Disposable ECG Electrodes
EUDAMEDClass I (EU MDR)
Ref TN13Model 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 EUDAMEDTN13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978812870293 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
Disposable ECG Electrodes by Shanghai Heramed Tech Co., Ltd. — 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 | 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 b3fcade6-966e-4fb9-b10d-8153e6b5abc1 61 fields · synced Jun 19, 2026