Identity
- Trade Name
- Solix Essential EUDAMED
- Device Name
- Solix EUDAMED
- Model / Reference
- Solix Essential EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858848006261 EUDAMED
- Basic UDI-DI
- 08588480068037K EUDAMED
- Direct Marketing DI
- 00858848006261 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Solix Essential by Optovue, Inc. — 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 | 08588480068037K | Class IIa | Active |
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Manufacturer
- Manufacturer
- Optovue, Inc.
- EUDAMED SRN
- US-MF-000018369
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED c1046b7c-56a7-4637-a50a-ed838d8f03be 61 fields · synced Jul 12, 2026