Identity
- Trade Name
- POLAOPTO EUDAMED
- Device Name
- Digital Vision Chart EUDAMED
- Model / Reference
- PO-1001 EUDAMEDPOL-CAT-PO-1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809897630046 EUDAMED
- Basic UDI-DI
- 880989763PO-1001UB EUDAMED
- Direct Marketing DI
- 08809897630046 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER 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
Polaopto by POLAOPTO Co., Ltd — 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 | 880989763PO-1001UB | Class I | Active |
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Manufacturer
- Manufacturer
- POLAOPTO Co., Ltd
- EUDAMED SRN
- KR-MF-000048815
- Authorised Representative
- SOAR & PARTNERS Sp. z o.o. PL-AR-000040956
Sources (1)
- EUDAMED e12edaa5-8a98-45f1-bc37-0026e2116ee3 61 fields · synced Jun 18, 2026