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Trackit T4EEG Amplifier
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2705Model Trackit T4 EEG Amplifier
Identity
- Trade Name
- Trackit T4EEG 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 EUDAMED2705 EUDAMEDT4-68 + BT Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060275450554 EUDAMEDFDA UDI
- Basic UDI-DI
- 506027545T4P7 EUDAMED
- FDA Product Code
- GWL FDA UDIGWQ 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
- 882.1835 FDA UDI882.1400 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 T4EEG Amplifier by Lifelines Ltd. — Class IIa — 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 | 506027545T4P7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lifelines Ltd.
- EUDAMED SRN
- GB-MF-000020001
- Authorised Representative
- Incereb Ltd IE-AR-000002462
Sources (2)
- EUDAMED e38800dc-7f31-4257-b4a4-5fc347ef9259 61 fields · synced Jun 19, 2026
- FDA UDI b2976b86-6f9a-44cd-841a-63aa76ae8c73 34 fields · synced May 30, 2026