Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Lumina 3D-e

UDI-DI 08594208280040Basic UDI-DI 859420828BIOMAGLUMINA3DSA

Class IIa · MDR · Karel Hrnčíř - BIOMAG

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Identification

Model: BIOMAG® Lumina 3D-e s aplikátory
EMDN: Z120606
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2024-MDR/QS-001/A

EU quality management system · unknown

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

Valid from 2026-05-30 · Expiry 2029-01-31

Scope not stated in certificate data.

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

Manufacturer

Karel Hrnčíř - BIOMAG

SRN CZ-MF-000025009

CZ · Chomutice

manufacturer

Related UDI-DIs

Lumina 3D-e 08594208280019
Lumina 3D-e 08594208280033
Lumina 3D-e 08594208280026

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/lumina-3d-e-0040 · UDI page: /udi/08594208280040

All devices from Karel Hrnčíř - BIOMAG

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