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iSage Rx

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref NAModel DSC-xx-001, where xx is Country dependent (ex. Italy Model Number – DSC-IT-001)510(k) K242066

by Amalgam Rx, Inc

Identity

Trade Name
iSage Rx EUDAMED
Device Name
Dose Check EUDAMED
Model / Reference
DSC-xx-001, where xx is Country dependent (ex. Italy Model Number – DSC-IT-001) EUDAMED
NA EUDAMED

Identifiers

Primary DI / UDI-DI
00850006610020 EUDAMED
Basic UDI-DI
0850006610ISPXX EUDAMED
Direct Marketing DI
00850006610020 EUDAMED
EMDN Code
V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Special Device Type
Software EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

iSage Rx by Amalgam Rx, Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Amalgam Rx, Inc
EUDAMED SRN
US-MF-000021912
FDA Applicant
Amalgam Rx, Inc.
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (3)

  • EUDAMED ba416a93-83ab-4568-86ec-b86ee6792a08 85 fields · synced Jul 20, 2026
  • EUDAMED ba416a93-83ab-4568-86ec-b86ee6792a08-1 61 fields · synced Jul 20, 2026
  • FDA 510(k) K242066 1 fields · synced May 18, 2026