Identity
- Trade Name
- READING GLASS EUDAMED
- Device Name
- Rosa Brillo;Tortoise Mate;Transparente Brillo EUDAMED
- Model / Reference
- REDONDA EUDAMEDCRF-RED-250 Rosa Brillo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975944900478 EUDAMED
- Basic UDI-DI
- 697594490REDONDAAY EUDAMED
- Direct Marketing DI
- 06975944900478 EUDAMED
- EMDN Code
- Q0210010102 MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL) 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
Reading Glass by Wenzhou Changhui International Trade 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 | 697594490REDONDAAY | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Changhui International Trade Co., Ltd.
- EUDAMED SRN
- CN-MF-000031322
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED d318af14-13e3-449f-ad1a-9d9b9abe298e 61 fields · synced Jun 18, 2026