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Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Preloaded Aspheric Intraocular Lens

UDI-DI 06974200256489Basic UDI-DI 697420025P030102090201P9B

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

Identification
Model
AS-P22, AS1-P22, AS2-P22, AS3-P22
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

6128787TD03

EU technical documentation assessment · valid

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

Valid from 2026-01-15 · Expiry 2031-01-01

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/preloaded-aspheric-intraocular-lens-6489 · UDI page: /udi/06974200256489

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