Identity
- Trade Name
- Faros FDA UDI
- Generic Name
- Electrocardiograph, professional, single-channel FDA UDI
- Device Name
- Device for 1-channel ECG and motion measurement and data collection FDA UDI
- Model / Reference
- Faros 90 FDA UDI
- Description
- Device for 1-channel ECG and motion measurement and data collection FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035220151 FDA UDI
- 510(k) Number
- K143032 FDA UDI
- FDA Product Code
- DXH FDA UDI
- GMDN Term
- Electrocardiograph, professional, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiograph, professional, single-channel
Faros by Bittium Biosignals , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143032 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bittium Biosignals , Ltd.
Sources (1)
- FDA UDI 29aecfc4-4901-4641-bc4a-c36dca97a1ed 35 fields · synced May 30, 2026