Identity
- Trade Name
- Photic Stimulator EUDAMEDLifelines Photic Stimulator FDA UDI
- Generic Name
- Visual stimulator FDA UDI
- Device Name
- Photic EUDAMED
- Model / Reference
- Photic EUDAMED1290 EUDAMEDPhotic Stimulator FDA UDI
Identifiers
- Catalog Number
- 1290 FDA UDI
- Primary DI / UDI-DI
- 05060275450165 EUDAMEDFDA UDI
- Basic UDI-DI
- 506027545PH1E2 EUDAMED
- 510(k) Number
- K101691 FDA UDI
- FDA Product Code
- GWE FDA UDI
- EMDN Code
- Z129005 GENERIC PHOTOSTIMULATORS EUDAMED
- GMDN Term
- Visual stimulator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1890 FDA UDI
- Market of Registration
- Netherlands 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
Photic Stimulator by Lifelines Ltd. — Class I — 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 | 506027545PH1E2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 610e0119-feee-4518-878b-93ad52ca8a73 61 fields · synced Jun 20, 2026
- FDA UDI 621a41ed-19fd-4530-88a6-fe4e00b5be37 35 fields · synced May 30, 2026