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Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Intraocular Lens

UDI-DI 06974200255482Basic UDI-DI 697420025P030102090201V7

Class IIb · MDR · Henan Simedice Biotechnologies Co.,Ltd.

Identification
Model
SM60AS, SM60AS1, SM60AS2, SM60AS3
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

6128787TD01

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2024-12-23 · Expiry 2029-12-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

6128787CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-01-15 · Expiry 2029-12-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Henan Simedice Biotechnologies Co.,Ltd.

SRN CN-MF-000017957

CN · Zhengzhou, Henan

manufacturer

Authorised representative: MedNet EC-REP C IIb GmbH (DE-AR-000011194)

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Canonical device page: /device/intraocular-lens-5482 · UDI page: /udi/06974200255482

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