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Rosa Brillo +2 more models
EUDAMEDClass I (EU MDR)
Ref CRF-RED-350 Tortoise MateModel REDONDA
Identity
- Device Name
- Rosa Brillo;Tortoise Mate;Transparente Brillo EUDAMED
- Model / Reference
- REDONDA EUDAMEDCRF-RED-350 Tortoise Mate EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975944900546 EUDAMED
- Basic UDI-DI
- 697594490REDONDAAY EUDAMED
- Direct Marketing DI
- 06975944900546 EUDAMED
- EMDN Code
- Q0210010102 MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL) EUDAMED
- Models / Variants
- Rosa Brillo EUDAMEDTortoise Mate EUDAMEDTransparente Brillo 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
Rosa Brillo +2 more models by Wenzhou Changhui International Trade Co., Ltd. — Class I — MDR — listed in EUDAMED — 3 models — 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 58428e65-38e6-49d9-84d3-943f85580567 61 fields · synced Jun 18, 2026