Aquaflush® 500X Transanal Irrigation System – SRC Starter Set – Procedure Pack

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Device Name

Aquaflush® Transanal irrigation system – Procedure pack

Model / Reference

SPAF5XSRC-EU

Primary DI / UDI-DI

05060458871343

Basic UDI-DI

5060463890000PPVC0T5

EMDN Code

G99 Gastrointestinal devices - other

Device Class

Class I

Medical Purpose

The intended use of the product is for transanal irrigation of the bowel in adults and children 3 years and above with a bowel dysfunction, who have been assessed and trained by an appropriate healthcare professional.

EUDAMED SRN

CN-PR-000056275

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