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Trackit T4 EEG Amplifier
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1506Model Trackit T4 EEG Amplifier
Identity
- Trade Name
- Trackit T4 EEG Amplifier EUDAMEDTrackit T4 FDA UDI
- Generic Name
- Electroencephalographic ambulatory recorder FDA UDI
- Device Name
- Trackit T4 EEG Amplifier EUDAMED
- Model / Reference
- Trackit T4 EEG Amplifier EUDAMED1506 EUDAMEDT4-32 + BT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060275450516 EUDAMEDFDA UDI
- Basic UDI-DI
- 506027545T4P7 EUDAMED
- FDA Product Code
- GWQ FDA UDIGWL FDA UDI
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
- GMDN Term
- Electroencephalographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI882.1835 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Trackit T4 EEG Amplifier by Lifelines Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172271 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K010460 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506027545T4P7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lifelines Ltd.
- EUDAMED SRN
- GB-MF-000020001
- Authorised Representative
- Incereb Ltd IE-AR-000002462
Sources (3)
- EUDAMED d47149aa-ca64-494b-9be2-fac0d1ce1e72 61 fields · synced Jul 26, 2026
- FDA UDI f6255c7e-23f7-432c-9323-2453015bf629 34 fields · synced May 30, 2026
- FDA 510(k) K172271 1 fields · synced May 18, 2026