Uromat HD

by Oldelft Benelux B.V. Netherlands EUDAMED

Ref UROxxxxModel Uromat HD

EMDN Z11039012

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number8720256816Uromat_HD59 Basic UDI-DI	Date12 Feb 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: Uromat HD, UROxxxx

Primary DI / UDI-DI: 18720256816611
Basic UDI-DI: 8720256816Uromat_HD59
EMDN Code: Z11039012 X-ray tube assembly

Device Class: Class IIb
Medical Purpose: This system is intended for urological procedures to simoultaniously use ultrasonic probes and xray imaging

Manufacturer details

EUDAMED SRN: NL-PR-000013761

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Properties & raw data

Show properties, registry sources and raw records

Other properties (1)

Sterile: No

Sources (1)

EUDAMED cb157426-450d-4848-b775-74bf36e31604 61 fields · synced 22 Oct 2026