Certificate valid

Snapshot 2026-10-19 · Link to EUDAMED

Carillon Curved Delivery Catheter

UDI-DI 00819833021133Basic UDI-DI 081983302CarillonB5

Class III · MDR · Cardiac Dimensions, Inc.

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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)

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Carillon Mitral Contour System (CMCS) 00819833020334
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Carillon Mitral Contour System (CMCS) 00819833020402
Carillon Mitral Contour System (CMCS) 00819833020426
Carillon Mitral Contour System (CMCS) 00819833020242
Carillon Mitral Contour System (CMCS) 00819833020501
Carillon Mitral Contour System (CMCS) 00819833020433
Carillon Mitral Contour System (CMCS) 00819833020716
Carillon Mitral Contour System (CMCS) 00819833020105
Carillon Mitral Contour System (CMCS) 00819833020303
Carillon Mitral Contour System (CMCS) 00819833020693
Carillon Mitral Contour System (CMCS) 00819833020747

Showing 12 of 77 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/carillon-curved-delivery-catheter-1133 · UDI page: /udi/00819833021133

All devices from Cardiac Dimensions, Inc.

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