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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

DryFlowEx PNH High-Sensitivity Assay Kit

UDI-DI 08594208060116Basic UDI-DI 859420806ED775074

Class C · IVDR · EXBIO Praha, a.s.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

2024-IVDR/QS-004

EU quality management system · unknown

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

Valid from 2024-12-04 · Expiry 2029-06-11

Scope not stated in certificate data.

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

Manufacturer

EXBIO Praha, a.s.

SRN CZ-MF-000033468

CZ · Vestec

manufacturer

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/dryflowex-pnh-high-sensitivity-assay-kit-0116 · UDI page: /udi/08594208060116

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