Identity
- Trade Name
- Ophthalmology EUDAMED
- Device Name
- OPH (Ophthalmology) EUDAMED
- Model / Reference
- OPH 02 EUDAMEDSYN-OPH02-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834053 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP005Z9 EUDAMED
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Ensures sterility in eye surgeries by offering necessary sterile instruments and drapes. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Orthopaedic guidewire, reusable
Ophthalmology by SYNDEO Medical — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5065021834SYNPP005Z9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED a31e7731-cf88-4458-b452-b959c31feb15 61 fields · synced Jun 18, 2026