Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Acti-fine 1ml Luer

UDI-DI 08586015049064Basic UDI-DI 858601504TUBERCULIN04LN

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

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Identification

Model: Tuberculin syringe
EMDN: A020109
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

Related UDI-DIs

CHIRANA 1ml 29G x 1/2" 08586015045141
CHIRANA 1ml Luer 08586015045158
CHIRANA 1ml Luer (flat rubber) 08586015048753

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/acti-fine-1ml-luer-9064 · UDI page: /udi/08586015049064

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

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