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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Dose Check

UDI-DI 00860008440129Basic UDI-DI 0850006610ISPXX

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

Amalgam Rx, Inc

SRN US-MF-000021912

US · Wilmington

manufacturer

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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/dose-check-0129 · UDI page: /udi/00860008440129

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