Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

CHIRAPLUS BLUE

UDI-DI 08586015043529Basic UDI-DI 858601504SPIKE20UA

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

Scan an inventory CSV

Identification

Model: Spike
EMDN: A04010199
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2022-MDR/QS-024/B

EU quality management system · unknown

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

Valid from 2026-05-28 · 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

CHIRAPLUS GREEN 08586015043543
CHIRAPLUS RED 08586015043505

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/chiraplus-blue-3529 · UDI page: /udi/08586015043529

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

Scan an inventory CSV