Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

CHIRANA 0,5ml with needle 28G x 1/2” (12,7mm) U100

UDI-DI 08586026570366Basic UDI-DI 858601504INSULIN04W7

Class IIa · MDR · CHIRANA T.Injecta, a.s.

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Identification

Model: Insulin syringe
EMDN: A02010601
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2022-MDR/QS-026/D

EU quality management system · unknown

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

Valid from 2025-11-28 · Expiry 2027-09-30

Scope not stated in certificate data.

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

Manufacturer

CHIRANA T.Injecta, a.s.

SRN SK-MF-000003702

SK · Stará Turá

manufacturer

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CHIRANA 0,3ml with needle 30G x 1/2” (12,7mm) U100 08586015047596
CHIRANA 0,3ml with needle 30G x 1/2” (12,7mm) U100 08586015045226
CHIRANA 0,3ml with needle 30G x 1/2” (12,7mm) U40 08586026571905
CHIRANA 0,3ml with needle 30G x 1/2” (12,7mm) U40 08586015048982
CHIRANA 0,3ml with needle 30G x 4/16” (6mm) U100 08586026570342
CHIRANA 0,3ml with needle 30G x 4/16” (6mm) U100 08586026571806

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/chirana-0-5ml-with-needle-28g-x-1-2-12-7mm-u100-0366 · UDI page: /udi/08586026570366

All devices from CHIRANA T.Injecta, a.s.

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