Identity
- Trade Name
- 1.56 EUDAMED
- Device Name
- 1.56 EUDAMED
- Model / Reference
- 1.56 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08808995040009 EUDAMED
- Basic UDI-DI
- 880899504000N5 EUDAMED
- EMDN Code
- Q0210010101 MONOFOCAL ORGANIC OPHTHALMIC LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
1.56 by Korea Optical 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 | 880899504000N5 | Class I | Active |
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Manufacturer
- Manufacturer
- Korea Optical Co., Ltd.
- EUDAMED SRN
- KR-MF-000008719
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 447743e9-9ac3-463c-a59c-a97691f494b7 61 fields · synced Jul 17, 2026