Identity
- Trade Name
- OKO z dwoma optotypami litery, obrazki EUDAMED
- Device Name
- Tablica okulistyczna EUDAMED
- Model / Reference
- OKO EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903684809110 EUDAMED
- Basic UDI-DI
- 590368480M007BM EUDAMED
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
OKO z dwoma optotypami litery, obrazki by Meden Inmed 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 | 590368480M007BM | Class I | Active |
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Manufacturer
- Manufacturer
- Meden-Inmed Sp. Z O.o.
- EUDAMED SRN
- PL-MF-000001670
Sources (1)
- EUDAMED c0b1ca53-6d3d-47bf-923e-bd649ee614f0 61 fields · synced Jul 24, 2026