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MiniSnap Sensitive 1-CH ECG Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9404718Model OmegaSnap
Identity
- Trade Name
- MiniSnap Sensitive 1-CH ECG Electrode EUDAMEDBittium OmegaSnap FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- ECG electrodes EUDAMEDBittium MiniSnap Sensitive 1-CH ECG Electrode FDA UDI
- Model / Reference
- OmegaSnap EUDAMED9404718 EUDAMED1-CH ECG Electrode FDA UDI
- Description
- Bittium MiniSnap Sensitive 1-CH ECG Electrode FDA UDI
Identifiers
- Catalog Number
- 9404718 FDA UDI
- Primary DI / UDI-DI
- 06430035220694 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
MiniSnap Sensitive 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 27157ae5-78db-42b6-93d7-3dffb9120039 61 fields · synced Jun 18, 2026
- FDA UDI 1d150f34-2c94-48c9-8436-fcaf4b4066e8 34 fields · synced May 30, 2026