Identity
- Trade Name
- Lunettes de lecture EUDAMED
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- 12037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974384060346 EUDAMED
- Basic UDI-DI
- 697438406OPGLRU EUDAMED
- Direct Marketing DI
- 06974384060346 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
Lunettes de lecture 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 (1)
- EUDAMED 80a7aeec-da9a-4858-8e5d-c157c61ec471 61 fields · synced Jun 18, 2026