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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

fixOflex

UDI-DI 05213014810038Basic UDI-DI 521301481fixOflexCX

Class IIb · MDR · EYE PCR BV

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

C08 NL037443 2601

EU quality management system · valid

Notified body: HTCert (Health Technology Certification Ltd) (2803)

Valid from 2026-07-24 · Expiry 2031-01-06

Scope not stated in certificate data.

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

C07 NL037443 2601

EU technical documentation assessment · valid

Notified body: HTCert (Health Technology Certification Ltd) (2803)

Valid from 2026-07-24 · Expiry 2031-01-06

Scope not stated in certificate data.

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

Manufacturer

EYE PCR BV

SRN NL-MF-000037443

NL · Amsterdam

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fixoflex-0038 · UDI page: /udi/05213014810038

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