Identity
- Trade Name
- Reading glasses EUDAMED
- Device Name
- Reading glasses EUDAMEDoptical glasses EUDAMED
- Model / Reference
- 441525 EUDAMED1 EUDAMED441526 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975457072211 EUDAMED06975457072228 EUDAMED
- Basic UDI-DI
- 697545707441525Z3 EUDAMED697545707441526Z5 EUDAMED
- Direct Marketing DI
- 06975457072228 EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMEDQ0210030101 READY TO WEAR METAL SPECTACLES WITH ORGANIC LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Surgical binoculars, reusable
Reading glasses by Wenzhou Wanray Glasses Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical binoculars, reusable.
- Brilliance — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class I
- Enova Illumination — ENOVA ILLUMINATION, INC · Class I
- SurgiTel — Surgitel · Class I
- Surgical Telescope — Xenosys Co., Ltd. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SuperVu XL Advantage 3.5x, at 34cm working distanc — Rudolf Riester GmbH & Co. KG · Class I
- Surgical Telescope — Xenosys Co., Ltd. · Class I
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 | 697545707441525Z3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wenzhou Wanray Glasses Co., Ltd
- EUDAMED SRN
- CN-MF-000025847
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (2)
- EUDAMED 5e9d81e0-812e-40fc-859e-185dcc80261e 61 fields · synced Jul 15, 2026
- EUDAMED d9f9e2ab-854b-4e95-989a-05b525bfff2d 61 fields · synced May 17, 2026