Identity
- Trade Name
- Optical Frames EUDAMED
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- 0536M/CRYSTAL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974384068618 EUDAMED
- Basic UDI-DI
- 697438406OPGLRU EUDAMED
- Direct Marketing DI
- 06974384068618 EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Frames by Wenzhou Innovision Optical Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951168 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697438406OPGLRU | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Innovision Optical Co., Ltd
- EUDAMED SRN
- CN-MF-000009602
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED cca448dc-9add-4816-b212-5d4432ab3090 61 fields · synced Jun 19, 2026
- FDA 510(k) K951168 1 fields · synced May 18, 2026