Identity
- Trade Name
- Skaitymo akiniai EUDAMED
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- 19002 EUDAMED19003 EUDAMED19005 EUDAMED19004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974384069974 EUDAMED06974384063965 EUDAMED06974384061251 EUDAMED06974384067079 EUDAMED
- Basic UDI-DI
- 697438406OPGLRU EUDAMED
- Direct Marketing DI
- 06974384069974 EUDAMED06974384063965 EUDAMED06974384061251 EUDAMED06974384067079 EUDAMED
- EMDN Code
- Q0210030102 READY TO WEAR PLASTIC SPECTACLES WITH ORGANIC LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Skaitymo akiniai by Wenzhou Innovision 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 | 697438406OPGLRU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wenzhou Innovision Optical Co., Ltd
- EUDAMED SRN
- CN-MF-000009602
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (4)
- EUDAMED 5e20781e-1471-442e-99b6-69a28464f885 61 fields · synced Oct 6, 2026
- EUDAMED 51e79cf8-37ef-4e4f-9f8c-120a2a458e02 61 fields · synced May 17, 2026
- EUDAMED da259c1f-50d2-4e93-856d-8e3e8e0d5fe9 61 fields · synced May 17, 2026
- EUDAMED d20a3e14-bb1f-4744-9531-75f3e57ed94c 61 fields · synced May 18, 2026