Identity
- Device Name
- Optical Frame EUDAMED
- Model / Reference
- LXGL EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974852470028 EUDAMED06974852470066 EUDAMED06974852470035 EUDAMED06974852470011 EUDAMED06974852470042 EUDAMED
- Basic UDI-DI
- 697485247opticalframeGG EUDAMED
- EMDN Code
- Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT 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
Optical Frame 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 | 697485247opticalframeGG | 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 (5)
- EUDAMED ac70afa9-d4ff-4232-b9f2-96416cbc037d 61 fields · synced Jul 19, 2026
- EUDAMED 8cc1a3e0-4a02-4fa1-8e55-daec45748f4a 61 fields · synced May 16, 2026
- EUDAMED f4e6a719-c47d-4721-9a03-7ad226ad5129 61 fields · synced May 17, 2026
- EUDAMED 696011c9-b94c-4082-acea-347d59dd5fa6 61 fields · synced May 17, 2026
- EUDAMED a05be821-56e6-464c-a853-736c6343ed05 61 fields · synced May 19, 2026