OmegaSnap 2-CH ECG Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- OmegaSnap 2-CH ECG Electrode EUDAMEDBittium OmegaSnap FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- ECG electrodes EUDAMED2-CH ECG Electrode FDA UDI
- Model / Reference
- OmegaSnap EUDAMED9404716 EUDAMED2-CH ECG Electrode FDA UDI
- Description
- 2-CH ECG Electrode FDA UDI
Identifiers
- Catalog Number
- 9404716 FDA UDI
- Primary DI / UDI-DI
- 06430035220670 EUDAMEDFDA UDI
- Basic UDI-DI
- 643003522ECGElectrodeTY EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electrocardiographic electrode, single-use
OmegaSnap 2-CH ECG Electrode by Bittium Biosignals Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 643003522ECGElectrodeTY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-MF-000013983
Sources (2)
- EUDAMED c15d5ee6-161d-4947-9e6f-062b17be5bf7 61 fields · synced Jun 17, 2026
- FDA UDI d0681f95-f322-415b-a30c-e099b14c9694 34 fields · synced May 30, 2026