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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Surgical drapes

UDI-DI 08591527006443Basic UDI-DI 8591527000100ISPB

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

Identification
Model
Cardiovascular, ENT, General, Gynaecology, Incision, Laparoscopic, Mini-invasive, Multi-organ, Neurosurgery, Ophthalmology, Orthopaedic, Plastic, Stomatology, Thoracic, Urology, Vascular, Interventional radiology, EsySuit, Other
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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/surgical-drapes-6443 · UDI page: /udi/08591527006443

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