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CARBON MEDICAL TECHNOLOGIES, INC.

USA · St. Paul

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 4Class III 1

plus 18 registration records and 18 510(k), 21 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class IV 1

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States18 registration records, 18 510(k), 21 PMA, 6 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: CARBON MEDICAL TECHNOLOGIES, INC.

FDA 510(k) clearances by year

12002

22003

22004

12006

12007

12010

12011

22013

22014

12017

12019

12021

12025

12026

FDA listed device types

Accelerator, Linear, Medical 1Staple, Implantable 1Endoscopic Injection Needle, Gastroenterology-Urology 1Marker, Radiographic, Implantable 1Agent, Bulking, Injectable For Gastro-Urology Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253598	InjecSURE Injection System	2026-03-31
US	K251748	MammoSTAR Biopsy Site Identifier	2025-07-23
US	K211590	Fiducial Marker	2021-06-10
CA	62615	INTEXEN PORCINE DERMAL MATRIX	Class IV

CARBON MEDICAL TECHNOLOGIES, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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