Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

Surgical drapes

UDI-DI 08591527187746Basic UDI-DI 8591527000100ISPB

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

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Identification

Model: Cardiovascular, ENT, General, Gynaecology, Incision, Laparoscopic, Mini-invasive, Multi-organ, Neurosurgery, Ophthalmology, Orthopaedic, Plastic, Stomatology, Thoracic, Urology, Vascular, Interventional radiology, EsySuit, Other
EMDN: T020102
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2023-MDR/QS-044

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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Canonical device page: /device/surgical-drapes-7746 · UDI page: /udi/08591527187746

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

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