OmegaSnap 1-CH Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- OmegaSnap 1-CH Adapter EUDAMEDBittium OmegaSnap FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- ECG electrodes EUDAMEDBittium OmegaSnap 1-CH Adapter FDA UDI
- Model / Reference
- OmegaSnap EUDAMED9400147 EUDAMED1-CH Adapter FDA UDI
- Description
- Bittium OmegaSnap 1-CH Adapter FDA UDI
Identifiers
- Catalog Number
- 9400147 FDA UDI
- Primary DI / UDI-DI
- 06430035220588 EUDAMEDFDA UDI
- Basic UDI-DI
- 643003522ECGElectrodeTY EUDAMED
- Direct Marketing DI
- 06430035220588 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 1-CH Adapter by Bittium Biosignals Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 c20c37d5-4408-4210-b52c-5263996f5dd8 61 fields · synced Jul 28, 2026
- FDA UDI d9162083-89c8-442a-a53b-a7ee39811be0 34 fields · synced May 30, 2026