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Carbon Medical Technologies, Inc.

United States·US-MF-000044355

Last updated September 17, 2026

About

Today, Carbon Medical Technologies (CMT) is one of only five organizations worldwide with a dedicated pyrolytic carbon coating facility, allowing us to engineer and manufacture devices that are durable, dependable, and trusted by clinicians. Over the past three decades, we’ve built a portfolio of clinically proven products that support patients, simplify procedures, and raise the standard of care across multiple specialties.

From the manufacturer's own website. Source

What Carbon Medical Technologies, Inc. makes

Carbon Medical Technologies, Inc. manufactures implantable radiological image markers, submucosal injection needles, synthetic polymer urinary tract reconstructive materials, non-medicated single-use general surgical procedure kits, single-use general-purpose endoscopic needles, and single-use needle guides.

The company's devices are classified as Class II, Class III, and Class IIb and are listed in Eudamed, FDA 510(k), FDA PMA, and FDA UDI databases. Carbon Medical Technologies, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Carbon Medical Technologies, Inc. manufacture?

Where is Carbon Medical Technologies, Inc. based?

Carbon Medical Technologies, Inc. is based in the United States, as indicated by the COUNTRY field in the device data, which specifies US as the company's location.

In which regulatory registries are Carbon Medical Technologies, Inc.'s devices listed?

The company's devices are listed in Eudamed, FDA 510(k), FDA PMA, and FDA UDI databases, as directly stated in the LISTED IN field and confirmed in the SUMMARY section of the provided data.

How are Carbon Medical Technologies, Inc.'s devices classified?

The devices manufactured by Carbon Medical Technologies, Inc. are classified as Class II, Class III, and Class IIb, as explicitly listed in the DEVICE CLASSES field and reiterated in the SUMMARY, reflecting the regulatory risk-based categorization applicable to their products.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 1290, HAMMOND ROAD, SAINT PAUL, United States
Website: WWW.CARBONMED.COM
LinkedIn: linkedin.com/company/carbon-med-technologies-inc/mycompany
Facebook: facebook.com/Carbon-Medical-Technologies-Inc-109530911330572
Email: [email protected]
Phone: 1 651 653 8512
PRRC Contact: ERIC FURLICH
EUDAMED SRN: US-MF-000044355
FDA FEI Number: 3002619738
DUNS Number: —

Catalogue (111)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
BiomarC PRO Fiducial Marker	040148	EUDAMED	Class IIb	Active
BiomarC EX Fiducial Marker	040157	EUDAMED	Class IIb	Active
BiomarC PRO Fiducial Marker	040149	EUDAMED	Class IIb	Active
BiomarC EX Fiducial Marker	040146	EUDAMED	Class IIb	Active
BiomarC EX Fiducial Marker	040160	EUDAMED	Class IIb	Active
BiomarC EX Fiducial Marker	040145	EUDAMED	Class IIb	Active
BiomarC Enh Fiducial Marker	040117	EUDAMED	Class IIb	Active
BiomarC Enh Fiducial Marker	040159	EUDAMED	Class IIb	Active
BiomarC Secure Fiducial Marker	040150	EUDAMED	Class IIb	Active
BiomarC Enh Fiducial Marker	040158	EUDAMED	Class IIb	Active
BiomarC®	040122	FDA UDI	Class II	Active
BiomarC®	040240	FDA UDI	Class II	Active
BiomarC®	040229	FDA UDI	Class II	Active
MammoStar™	STAR0833	FDA UDI	Class II	Active
Carbon Bright®	040152	FDA UDI	Class II	Active
BiomarC®	040138	FDA UDI	Class II	Active
MammoStar™	STAR0831	FDA UDI	Class II	Active
MammoStar™	STAR1032	FDA UDI	Class II	Active
Durasphere ®	890-205	FDA UDI	Class II	Active
MammoStar™	STAR1102	FDA UDI	Class II	Active
Carbon Bright®	040151	FDA UDI	Class II	Active
BiomarC®	040230	FDA UDI	Class II	Active
MammoStar™	STAR1402	FDA UDI	Class II	Active
Durasphere ®	890-204	FDA UDI	Class II	Active
ImarC™	040301	FDA UDI	Class II	Unknown
BiomarC ®	040142	FDA UDI	Class II	Active
BiomarC®	040123	FDA UDI	Class II	Active
MammoStar™	STAR1101	FDA UDI	Class II	Active
Durasphere ® EXP	890-216	FDA UDI	Class III	Active
Biomarc® Restore	040156	EUDAMEDFDA UDI	Class II	Active
BiomarC®	040119	FDA UDI	Class II	Unknown
Biomarc ® Restore	040161	FDA UDI	Class II	Active
BiomarC®	040137	FDA UDI	Class II	Active
BiomarC®	040120	FDA UDI	Class II	Active
BiomarC ®	040133	FDA UDI	Class II	Active
BiomarC®	040123	FDA UDI	Class II	Unknown
ImarC™	040210	FDA UDI	Class II	Unknown
BiomarC®	040109	FDA UDI	Class II	Active
BiomarC®	040122	FDA UDI	Class II	Unknown
BiomarC®	040132	FDA UDI	Class II	Unknown
Carbon Bright ®	040166	FDA UDI	Class II	Active
BiomarC®	040315	FDA UDI	Class II	Active
Durasphere ® EXP	890-215	FDA UDI	Class III	Active
BiomarC®	040311	FDA UDI	Class II	Active
BiomarC®	040119	FDA UDI	Class II	Active
MammoStar™	STAR0832	FDA UDI	Class II	Active
MammoStar™	STAR0802	FDA UDI	Class II	Active
MammoStar™	STAR1121	FDA UDI	Class II	Active
ImarC™	040303	FDA UDI	Class II	Unknown
Biomarc ® Restore	040162	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Carbon Medical Technologies, Inc. has two FDA recall records initiated between December 16, 2022, and July 26, 2024. One recall involves mislabeling where the product is identified as STAR1401 (a 1x3mm Barbell marker) while the packaging contains STAR1402 (a 1x5mm Tribell marker). The other recall pertains to the omission of an MRI Insert that was supposed to be provided to the patient. The records show statuses of open, classified, and terminated.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 26, 2024	Z-3161-2024	—	open, classified	This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Dec 16, 2022	Z-1041-2023	—	terminated	The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.