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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

BiomarC Fiducial Marker

UDI-DI 10858015005971Basic UDI-DI 0858015005008V7

Class IIb · MDR · Carbon Medical Technologies, Inc.

Identification
Model
040113
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

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/biomarc-ex-fiducial-marker-5971 · UDI page: /udi/10858015005971

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