Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

BiomarC Fiducial Marker

UDI-DI 10850002461005Basic UDI-DI 0858015005008V7

Class IIb · MDR · Carbon Medical Technologies, Inc.

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Identification

Model: 040113
EMDN: A019012
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 818779

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-08-25 · Expiry 2030-08-12

Scope not stated in certificate data.

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

Manufacturer

Carbon Medical Technologies, Inc.

SRN US-MF-000044355

US · SAINT PAUL

manufacturer

Authorised representative: Donawa Lifescience Consulting Srl (IT-AR-000007785)

Related UDI-DIs

BiomarC Fiducial Marker 10858015005889
BiomarC Fiducial Marker 10858015005971
BiomarC Fiducial Marker 10858015005858
BiomarC Fiducial Marker 10850002461135

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/biomarc-secure-fiducial-marker-1005 · UDI page: /udi/10850002461005

All devices from Carbon Medical Technologies, Inc.

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