Identity
- Trade Name
- BiomarC Enh Fiducial Marker EUDAMED
- Device Name
- BiomarC Carbon Fiducial Marker EUDAMED
- Model / Reference
- 040117 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10858015005889 EUDAMED
- Basic UDI-DI
- B-10858015005889 EUDAMED
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BiomarC Enh Fiducial Marker by Carbon Medical Technologies, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10858015005889 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Carbon Medical Technologies, Inc.
- EUDAMED SRN
- US-MF-000044355
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (1)
- EUDAMED eeb0b4ca-9bf0-4a9c-8255-6d488f0e9a4c 61 fields · synced Jul 11, 2026