← Back to catalogue
Trackit T4A
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2800Model Trackit T4A EEG Amplifier
Identity
- Trade Name
- Trackit T4A EUDAMEDFDA UDI
- Generic Name
- Electroencephalographic ambulatory recorder FDA UDI
- Device Name
- Trackit T4A EEG Amplifier EUDAMED
- Model / Reference
- Trackit T4A EEG Amplifier EUDAMED2800 EUDAMEDT4A Kit FDA UDI
Identifiers
- Catalog Number
- 2800 FDA UDI
- Primary DI / UDI-DI
- 05060275450653 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060275450653 EUDAMED
- 510(k) Number
- K172271 FDA UDI
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 T4A by Lifelines Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060275450653 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lifelines Ltd.
- EUDAMED SRN
- GB-MF-000020001
- Authorised Representative
- Incereb Ltd IE-AR-000002462
Sources (2)
- EUDAMED ab5a5ff2-f3d7-410b-be2b-b49ca60aff4b 61 fields · synced May 30, 2026
- FDA UDI 573e7150-1465-4202-a156-6979a62f7b3b 35 fields · synced May 30, 2026