Identity
- Trade Name
- RETeval Flicker EUDAMED
- Device Name
- RETeval EUDAMED
- Model / Reference
- 00857901006484 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857901006484 EUDAMED
- Basic UDI-DI
- 0857901006RETeval53 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
RETeval Flicker by LKC Technologies — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0857901006RETeval53 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LKC Technologies
- EUDAMED SRN
- US-MF-000030631
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d2961b4d-c397-4144-bb1f-8df68ce7583c 61 fields · synced Jun 19, 2026