BiomarC® Restore

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 040155

by Carbon Medical Technologies, Inc.

Identity

Trade Name: BiomarC Restore Fiducial Marker EUDAMED
BiomarC® Restore FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: BiomarC Restore Fiducial Marker EUDAMED
LOW DENSITY FIDUCIAL MARKER FDA UDI
Model / Reference: 040155 EUDAMEDFDA UDI
Description: LOW DENSITY FIDUCIAL MARKER FDA UDI

Identifiers

Catalog Number: 040155 FDA UDI
Primary DI / UDI-DI: 00850002461091 EUDAMEDFDA UDI
Basic UDI-DI: B-00850002461091 EUDAMED
FDA Product Code: IYE FDA UDI
EMDN Code: A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 892.5050 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Width — 2 Centimeter FDA UDI
Height — 2 Centimeter FDA UDI
Length — 3 Centimeter FDA UDI
Length — 5 Millimeter FDA UDI
Height — 1 Millimeter FDA UDI

Category: Radiological image marker, implantable

BiomarC® Restore by Carbon Medical Technologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Carbon Medical Technologies, Inc.

Sources (2)

FDA UDI 8ce59b7e-a3b0-4a08-b98a-e0a420ca2eab 36 fields · synced Jul 19, 2026
EUDAMED c9f697ff-ada1-41b0-9cf9-5a284d356879 61 fields · synced Jul 19, 2026