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Carbon (shenzhen) Medical Device Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances

Name: Carbon (shenzhen) Medical Device Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Carbon (shenzhen) Medical Device Co., Ltd. is registered with the FDA (registration 3033858858) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 11, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3033858858
Address: Room 203, Building B, 5# Skyworth Innovation Vally No. 1 Tangtou Road, Tangtou Community, Shiyan Street, Bao'an District, Shenzhen Guangdong, China, 518102
Owner or operator: Carbon (Shenzhen) Medical Device Co., Ltd. (10091764)
Roles: Manufacturer
First device listed: October 31, 2024
Registered through: 2026
Brand names listed: Disposable Biopsy Needle(CMBNA/1810, CMBNA/1815, CMBNA/1820), Disposable Needle-guided Bracket (Model No.: VE-C01, VE-L01, VE-C02), Disposable Needle-guided Bracket Kit (Models: VE-CL01-33, VE-CL01-34, VE-CL01-35, VE-CL01-36, VE-CL01-37), Disposable Puncture Needle (Models: VN-T01-1.2(18G)x100, VN-T01-1.2(18G)x150, VN-T01-1.2(18G)x200), Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Holder, Syringe	IQG	1	Manufacturer	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 11, 2025	K243296	Disposable Biopsy Needle	KNW	Substantially Equivalent	Carbon (Shenzhen) Medical Device Co., Ltd.	accessdata.fda.gov
April 3, 2025	K243298	Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System	IYN	Substantially Equivalent	Carbon (Shenzhen) Medical Device Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.