Identity
- Device Name
- OculoSpect EUDAMED
- Model / Reference
- 697-202022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08605044404740 EUDAMED
- Basic UDI-DI
- 86050444OculoSpectSN EUDAMED
- EMDN Code
- Q0210010101 MONOFOCAL ORGANIC OPHTHALMIC LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia 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
OculoSpect by Opticus Doo Belgrade — Class I — 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 | 86050444OculoSpectSN | Class I | Active |
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Manufacturer
- Manufacturer
- Opticus Doo Belgrade
- EUDAMED SRN
- RS-MF-000041064
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED d2580450-0d91-47a1-b225-2cc5d1866c83 61 fields · synced Jun 18, 2026