Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

CHIRAFLEX 16G

UDI-DI 08586006512973Basic UDI-DI 858601504MANDRIN17J5

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

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Identification

Model: Mandrin
EMDN: A070501
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2022-MDR/QS-027/A

EU quality management system · unknown

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

Valid from 2024-12-12 · 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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CHIRAFLEX 18G 08586006512935
CHIRAFLEX 20G 08586006512911
CHIRAFLEX 22G 08586006512898
CHIRAFLEX 24 G 08586006512874
CHIRAFLEX 26G 08586015043932

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/chiraflex-16g-2973 · UDI page: /udi/08586006512973

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

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