Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Fixation elements

UDI-DI 08591527005040Basic UDI-DI 8591527000500ISQP

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

Scan an inventory CSV

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

Related UDI-DIs

Fixation elements 08591527158784
Fixation elements 08591527045893
Fixation elements 08591527005057
Fixation elements 08591527158791
Fixation elements 08591527016206
Fixation elements 08591527003947
Fixation elements 08591527274910
Fixation elements 08591527035443
Fixation elements 08591527064856
Fixation elements 08591527188644

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fixation-elements-5040 · UDI page: /udi/08591527005040

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

Scan an inventory CSV