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OmegaSnap 1-CH ECG Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9404644Model OmegaSnap
Identity
- Trade Name
- OmegaSnap 1-CH ECG Electrode EUDAMEDBittium OmegaSnap FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- ECG electrodes EUDAMED1-CH ECG Electrode FDA UDI
- Model / Reference
- OmegaSnap EUDAMED9404644 EUDAMED1-CH ECG Electrode FDA UDI
- Description
- 1-CH ECG Electrode FDA UDI
Identifiers
- Catalog Number
- 9404644 FDA UDI
- Primary DI / UDI-DI
- 06430035220519 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
OmegaSnap 1-CH ECG Electrode by Bittium Biosignals Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 d6f5338f-d541-4af9-b614-09c3ade8f4f6 61 fields · synced Jul 17, 2026
- FDA UDI 7ffd61b1-17b1-4253-b5c6-3e7814be1dd4 34 fields · synced May 30, 2026