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Preloaded Aspheric Intraocular Lens
EUDAMEDClass IIb (EU MDR)
Ref AS1-P22Model AS-P22, AS1-P22, AS2-P22, AS3-P22
Identity
- Device Name
- Preloaded Aspheric Intraocular Lens EUDAMED
- Model / Reference
- AS-P22, AS1-P22, AS2-P22, AS3-P22 EUDAMEDAS1-P22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976813260587 EUDAMED
- Basic UDI-DI
- 697420025P030102090201P9B EUDAMED
- Direct Marketing DI
- 06976813260587 EUDAMED
- EMDN Code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
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
Preloaded Aspheric Intraocular Lens by Henan Simedice Biotechnologies Co., Ltd. — Class IIb — 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 | 697420025P030102090201P9B | Class IIb | Active |
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Manufacturer
- Manufacturer
- Henan Simedice Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000017957
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 8639dec3-0a37-4911-beaf-5b265819bcef 61 fields · synced Aug 1, 2026