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Intraocular Lens
EUDAMEDClass IIb (EU MDR)
Ref US-SM60ASModel SM60AS, SM60AS1, SM60AS2, SM60AS3
Identity
- Device Name
- Intraocular Lens EUDAMED
- Model / Reference
- SM60AS, SM60AS1, SM60AS2, SM60AS3 EUDAMEDUS-SM60AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810109290000 EUDAMED
- Basic UDI-DI
- B-00810109290000 EUDAMED
- EMDN Code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Intraocular Lens by Simedice Biotechnologies Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810109290000 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Simedice Biotechnologies Inc.
- EUDAMED SRN
- US-MF-000017961
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 00f09ac0-f303-440d-a942-4910d343ec12 61 fields · synced Jul 24, 2026