Carbon (Shenzhen) Medical Device Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 6 device types, 4 products catalogued, 2 clearances.
Carbon (Shenzhen) Medical Device Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Instrument, Biopsy, Adaptor, Holder, Syringe and 4 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | CARBON (SHENZHEN) MEDICAL DEVICE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3033858858 |
| FEI number | 3033858858 |
| DUNS | 702328173 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 卡本（深圳）医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440300MA5FL1HU0M |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 203, Building B, 5# Skyworth Innovation Vally |
| Postal code | 518102 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | Class 1 | 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) | 2024 | 15 |
| Device, Percutaneous, Biopsy | Class 1 | Disposable Puncture Needle (Models: VN-T01-1.2(18G)x100, VN-T01-1.2(18G)x150, VN-T01-1.2(18G)x200) | 2024 | 5 |
| Instrument, Biopsy | Class 2 | Disposable Biopsy Needle(CMBNA/1810, CMBNA/1815, CMBNA/1820) | 2025 | 9 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System | 2025 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System | 2025 | 37 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System | 2025 | 44 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243296 | 2025-07-11 | KNW | Traditional | This company |
| K243298 | 2025-04-03 | IYN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Main products | Intelligent Magnetic Navigation System, Medical fusion ultrasound |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.