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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

HLA B5701 Strip

UDI-DI 08429577002903Basic UDI-DI 84295773155WV

Class C · IVDR · OPERON, S.A.

Identification
Model
3.155.XXX.YY.ZZZ
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 1530337-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-04-16 · Expiry 2030-04-15

Scope not stated in certificate data.

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

Manufacturer

OPERON, S.A.

SRN ES-MF-000004790

ES · Cuarte de Huerva - Zaragoza

manufacturer

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hla-b5701-strip-2903 · UDI page: /udi/08429577002903

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