Identity
- Trade Name
- R40 EUDAMEDR-40 FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- R40 EEG Amplifier EUDAMED
- Model / Reference
- R40 EUDAMED1326 EUDAMEDEEG Amplifier FDA UDI
Identifiers
- Catalog Number
- 1326 FDA UDI
- Primary DI / UDI-DI
- 05060275450387 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060275450387 EUDAMED
- 510(k) Number
- K151600 FDA UDI
- FDA Product Code
- GWL FDA UDI
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1835 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
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
R40 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-05060275450387 | 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 714871b4-a03f-4617-a553-9857c19ab39f 61 fields · synced Jul 11, 2026
- FDA UDI e62f413d-b97b-4da9-8537-1ef14a19169c 35 fields · synced May 30, 2026