Identity
- Trade Name
- Sensor Strip Electrodes (Box of 50) EUDAMEDRETeval™ FDA UDI
- Generic Name
- Electroretinograph electrode FDA UDI
- Device Name
- Sensor Strips EUDAMEDBox of 50 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system. FDA UDI
- Model / Reference
- 95-068 EUDAMEDSensor Strips FDA UDI
- Description
- Box of 50 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system. FDA UDI
Identifiers
- Catalog Number
- Sensor Strips FDA UDI
- Primary DI / UDI-DI
- 10857901006009 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857901006Sensor-StripsEP EUDAMED
- 510(k) Number
- K142567 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Q029002 OPHTHALMOLOGICAL DIAGNOSTIC ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Electroretinograph electrode FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sensor Strip Electrodes (Box of 50) by LKC Technologies — 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 | 0857901006Sensor-StripsEP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LKC Technologies
- EUDAMED SRN
- US-MF-000030631
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED be093581-d999-432d-89c6-cb4fb35eb330 61 fields · synced Jul 25, 2026
- FDA UDI 84e404fc-318e-41fa-94cf-e111ae393d1b 36 fields · synced May 29, 2026