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Volcano brillo +2 more models
EUDAMEDClass I (EU MDR)
Ref CRF-OJO-300Model OJO GATO
Identity
- Device Name
- Volcano brillo;Havana blanco Brillo;Carey claro y varilla azul oscuro EUDAMED
- Model / Reference
- OJO GATO EUDAMEDCRF-OJO-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975944900331 EUDAMED
- Basic UDI-DI
- 697594490OJOGATODS EUDAMED
- Direct Marketing DI
- 06975944900331 EUDAMED
- EMDN Code
- Q0210010102 MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL) EUDAMED
- Models / Variants
- Volcano brillo EUDAMEDHavana blanco 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
Volcano 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 | 697594490OJOGATODS | 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 b9a85c59-3790-46d9-a39a-3114fb934dca 61 fields · synced Oct 6, 2026