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Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Carillon Mitral Contour System (CMCS)

UDI-DI 00819833020617Basic UDI-DI 081983302CarillonB5

Class III · MDR · Cardiac Dimensions, Inc.

Identification
Model
—
EMDN
P0799
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

3829984TD01

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2023-04-20 · Expiry 2028-04-20

Scope not stated in certificate data.

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

3829984CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2023-04-20 · Expiry 2028-04-20

Scope not stated in certificate data.

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

Manufacturer

Cardiac Dimensions, Inc.

SRN US-MF-000002426

US · Kirkland, Washington

manufacturer

Authorised representative: ICON (LR) Limited (IE-AR-000006507)

Related UDI-DIs

Showing 12 of 77 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/carillon-mitral-contour-system-cmcs-0617 · UDI page: /udi/00819833020617

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