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Yishiya
EUDAMEDClass I (EU MDR)
Ref compound eye biomimetic LensModel 1.60 compound eye biomimetic Lens
Identity
- Trade Name
- YISHIYA EUDAMED
- Device Name
- Optical lens EUDAMED
- Model / Reference
- 1.60 compound eye biomimetic Lens EUDAMEDcompound eye biomimetic Lens EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979028560022 EUDAMED
- Basic UDI-DI
- 6979028560022DY EUDAMED
- EMDN Code
- Q0210010101 MONOFOCAL ORGANIC OPHTHALMIC 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
Yishiya by Jiangsu Aixin Optics 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 | 6979028560022DY | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Aixin Optics Co., Ltd.
- EUDAMED SRN
- CN-MF-000047113
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 4c6f8bc3-91a6-4f5e-8f02-2ca27a06b596 61 fields · synced Jul 9, 2026