iSage Rx

Class IIa · MDR · Amalgam Rx, Inc

Identification

Model: DSC-xx-001, where xx is Country dependent (ex. Italy Model Number – DSC-IT-001)
EMDN: V92
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

28620177096

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2024-06-04 · Expiry 2028-10-02

Scope not stated in certificate data.

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

Manufacturer

SRN US-MF-000021912

US · Wilmington

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

Related UDI-DIs