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ECG Cable
EUDAMEDClass I (EU MDR)
Ref F1E0003Model F1E0003, F1E0005, F1E0004, F1E0006, F1K1001, F1K1002, F1K1003, F1KD001
Identity
- Device Name
- ECG Cable EUDAMED
- Model / Reference
- F1E0003, F1E0005, F1E0004, F1E0006, F1K1001, F1K1002, F1K1003, F1KD001 EUDAMEDF1E0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977704920009 EUDAMED
- Basic UDI-DI
- 697770492F1ECGCH5 EUDAMED
- EMDN Code
- Z12030680 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
ECG Cable by Shenzhen F1 Technology 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 | 697770492F1ECGCH5 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen F1 Technology CO., Ltd
- EUDAMED SRN
- CN-MF-000043372
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 76190dca-2e66-458e-8469-a312d8bb8d05 61 fields · synced Jul 14, 2026