Identity
- Device Name
- Toric Intraocular Lens EUDAMED
- Model / Reference
- ST1 EUDAMEDST1+10.5D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974200252061 EUDAMED
- Basic UDI-DI
- B-06974200252061 EUDAMED
- EMDN Code
- P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Toric Intraocular Lens by Henan Simedice Biotechnologies Co., Ltd. — 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-06974200252061 | 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 49cf6664-ab6a-467a-a554-d84be74bc88d 61 fields · synced Jun 18, 2026