Identity
- Trade Name
- uSee EUDAMED
- Device Name
- uSee Universal System for Eyesight Examination EUDAMED
- Model / Reference
- version 4.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141366 EUDAMED
- Basic UDI-DI
- 590329314100USEEQE EUDAMED
- EMDN Code
- Z1212012082 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland 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
uSee by Optopol Technology Sp Z O O — 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 | 590329314100USEEQE | Class I | Active |
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Manufacturer
- Manufacturer
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (1)
- EUDAMED 18db4544-2820-4b22-9453-c0bb32d7d873 61 fields · synced Jun 18, 2026