FDA Registration
Active
🇨🇳 China
CARBON (SHENZHEN) MEDICAL DEVICE CO., LTD.
Reg #: 3033858858
·
FEI: 3033858858
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- CARBON (SHENZHEN) MEDICAL DEVICE CO., LTD.
- Registration Number
- 3033858858
- FEI Number
- 3033858858
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 203, Building B, 5# Skyworth Innovation Vally, No. 1 Tangtou Road, Tangtou Community, Shiyan Street, Bao'an District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243298
Owner / Operator
- Firm Name
- Carbon (Shenzhen) Medical Device Co., Ltd.
- Operator Number
- 10091764
- Address
- Room 203, Building B, 5# Skyworth Innovation Vally, No. 1 Tangtou Road, Tangtou Community, Shiyan Street, Bao'an District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518102
- Country
- CN
- Correspondent
- Min Ye
US Agent
- Business Name
- SPICA MEDTECH CORP
- Contact Name
- Creekon Yang
- Address
- 1020 LINCOLN ST
- City
- Denver
- State
- CO
- ZIP
- 80203
- Country
- US
- [email protected]
- Phone
- 720 6176666
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2024-10-31 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2024-10-31 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-04-13 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-04-13 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-04-13 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-08-15 |
Proprietary Names
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
Disposable Biopsy Needle(CMBNA/1810, CMBNA/1815, CMBNA/1820)
Establishment Types
Manufacture Medical Device