Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Fixation elements

UDI-DI 08591527158784Basic UDI-DI 8591527000500ISQP

Class Is · MDR · DINA – HITEX, spol. s r.o.

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Identification

Model: DinaFix, OP tape
EMDN: M050101
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2023-MDR/QS-052

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2023-11-10 · Expiry 2028-11-10

Scope not stated in certificate data.

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

Manufacturer

DINA – HITEX, spol. s r.o.

SRN CZ-MF-000000312

CZ · Bučovice

manufacturer

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fixation-elements-8784 · UDI page: /udi/08591527158784

All devices from DINA – HITEX, spol. s r.o.

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