Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

ARTIFICIALIRIS FiberFree CUSTOMFLEX®

UDI-DI 04049154000029Basic UDI-DI 04049154_AI_M1_H1_O1_X7

Class IIb · MDR · HumanOptics Holding AG

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Identification

Model: —
EMDN: P0399
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

44912221836

EU technical documentation assessment · unknown

Notified body: TÜV NORD CERT GmbH (0044)

Valid from 2026-06-10 · Expiry 2030-06-12

Scope not stated in certificate data.

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

44911221836

EU quality management system · unknown

Notified body: TÜV NORD CERT GmbH (0044)

Valid from 2026-06-10 · Expiry 2030-06-12

Scope not stated in certificate data.

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

Manufacturer

HumanOptics Holding AG

SRN DE-MF-000017892

DE · Erlangen

manufacturer

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Showing 12 of 27 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/artificialiris-fiberfree-customflex-0029 · UDI page: /udi/04049154000029

All devices from HumanOptics Holding AG

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