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ECG Adhesive Single Lead Extra
EUDAMEDClass I (EU MDR)
Ref ECG Adhesive Single Lead ExtraModel ECG Adhesive
by Byteflies NV
Identity
- Trade Name
- ECG Adhesive Single Lead Extra EUDAMED
- Model / Reference
- ECG Adhesive EUDAMEDECG Adhesive Single Lead Extra EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430001718362 EUDAMED
- Basic UDI-DI
- 5430001718BF13000430LK EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Adhesive Single Lead Extra by Byteflies NV — 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 | 5430001718BF13000430LK | Class I | Active |
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Manufacturer
- Manufacturer
- Byteflies NV
- EUDAMED SRN
- BE-MF-000014680
Sources (1)
- EUDAMED e996350c-08a2-4da7-ad8f-95ede023fc1e 61 fields · synced Jul 27, 2026