Identity
- Device Name
- Spectacle Lens EUDAMED
- Model / Reference
- LXPAC EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974852470097 EUDAMED
- Basic UDI-DI
- 697485247spectaclelensKV EUDAMED
- EMDN Code
- Q0210010101 MONOFOCAL ORGANIC OPHTHALMIC LENSES EUDAMED
Classification
- Device Class
- Class I 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
Spectacle Lens by Luxin Optical (shanghai) 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 | 697485247spectaclelensKV | Class I | Active |
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Manufacturer
- Manufacturer
- Luxin Optical (shanghai) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012151
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 0f2efefe-3e04-4316-a9e9-3e864abfde60 61 fields · synced Jul 22, 2026