Identity
- Trade Name
- RETeval Complete EUDAMEDRETeval™ FDA UDI
- Generic Name
- Electroretinograph electrode FDA UDI
- Device Name
- RETeval EUDAMEDRETeval visual electrophysiology system - Complete model FDA UDI
- Model / Reference
- 00857901006040 EUDAMEDRETeval Complete FDA UDI
- Description
- RETeval visual electrophysiology system - Complete model FDA UDI
Identifiers
- Catalog Number
- RETeval Complete FDA UDI
- Primary DI / UDI-DI
- 00857901006040 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857901006RETeval53 EUDAMED
- 510(k) Number
- K142567 FDA UDI
- FDA Product Code
- HLG FDA UDIGXY FDA UDIGWE FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Electroretinograph electrode FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1700 FDA UDI882.1320 FDA UDI882.1890 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
RETeval Complete by LKC Technologies — 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 | 0857901006RETeval53 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- LKC Technologies
- EUDAMED SRN
- US-MF-000030631
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 23d13fbe-4370-47bd-98d3-5d9b499e1509 61 fields · synced Jun 18, 2026
- FDA UDI 9ff78c97-ffc5-4357-b086-af709cde1d41 36 fields · synced May 29, 2026