Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

BiomarC Tissue Marker System

UDI-DI 10858015005681Basic UDI-DI 0858015005003UV

Class IIb · MDR · Carbon Medical Technologies, Inc.

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Identification

Model: 040203
EMDN: A019012
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 777071

EU technical documentation assessment · unknown

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

Valid from 2026-08-25 · Expiry 2030-04-30

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)

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BiomarC Tissue Marker System 10858015005674
BiomarC Tissue Marker System 10858015005780
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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/biomarc-tissue-marker-system-5681 · UDI page: /udi/10858015005681

All devices from Carbon Medical Technologies, Inc.

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