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Sign in to claim this brandShenzhen Dakewe Bio-engineering Co., Ltd
US
Last updated May 30, 2026
What Shenzhen Dakewe Bio-engineering Co., Ltd makes
The company produces in vitro diagnostic (IVD) devices for clinical specimen collection and storage, including kits and swabs for oral and upper respiratory tract samples, as well as containers with additives or fixatives for general and tissue specimens. Products like the SNT Biotech, BioSci™, and DTPM series are designed for medical testing and laboratory use, ensuring compatibility with diagnostic workflows.
These devices are classified under FDA’s regulatory framework as either Class I or Class II, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable IVD regulations for specimen handling and processing equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shenzhen Dakewe Bio-engineering Co., Ltd specialize in producing?
Shenzhen Dakewe Bio-engineering Co., Ltd specializes in in vitro diagnostic (IVD) devices focused on clinical specimen collection and storage. Their products include general specimen collection kits, oral/upper respiratory tract specimen collection kits and swabs, as well as containers with additives or fixatives for general and tissue specimens. These devices are designed to support medical testing and laboratory workflows by ensuring proper sample handling and preservation.
Where is Shenzhen Dakewe Bio-engineering Co., Ltd based?
The company is based in the United States. This location ensures compliance with U.S. regulatory requirements for in vitro diagnostic devices, including those related to specimen collection and storage equipment.
Which regulatory registries list Shenzhen Dakewe Bio-engineering Co., Ltd’s devices?
Shenzhen Dakewe Bio-engineering Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks authorized medical devices under the FDA’s regulatory framework, ensuring transparency and traceability for Class I and Class II IVD products.
How are Shenzhen Dakewe Bio-engineering Co., Ltd’s devices classified under FDA regulations?
The company’s devices fall under two classification tiers in the FDA’s regulatory system: Class I and Class II. Class I devices generally pose minimal risk and require less stringent controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA guidelines.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 543029175
Catalogue (42)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SNT Biotech | VN | FDA UDI | Class I | Active |
| BioSci™ | VO | FDA UDI | Class I | Active |
| SNT Biotech | FB | FDA UDI | Class I | Active |
| BioSci™ | VO | FDA UDI | Class I | Active |
| SNT Biotech | MSB | FDA UDI | Class I | Active |
| Dtpm | ITMNO | FDA UDI | Class II | Active |
| BioSci™ | VM | FDA UDI | Class I | Active |
| Biosci™ | NP | FDA UDI | Class I | Active |
| Dakewe | ITMO | FDA UDI | Class II | Active |
| Dtpm | ITMNO | FDA UDI | Class II | Active |
| Dakewe | ITMT | FDA UDI | Class II | Active |
| BioSci™ | VN | FDA UDI | Class I | Active |
| Dakewe | ITMN | FDA UDI | Class II | Active |
| Dakewe | ITMM | FDA UDI | Class II | Active |
| Dakewe | ITMM | FDA UDI | Class II | Active |
| Dakewe | ITMT | FDA UDI | Class II | Active |
| BioSci™ | VNO | FDA UDI | Class I | Active |
| BioSci™ | VO | FDA UDI | Class I | Active |
| Dakewe | ITMN | FDA UDI | Class II | Active |
| BioSci™ | VN | FDA UDI | Class I | Active |
| BioSci™ | VNO | FDA UDI | Class I | Active |
| Dakewe | ITMN | FDA UDI | Class II | Active |
| SNT Biotech | VN | FDA UDI | Class I | Active |
| BioSci™ | VN | FDA UDI | Class I | Active |
| BioSci™ | VM | FDA UDI | Class I | Active |
| SNT Biotech | OP | FDA UDI | Class I | Active |
| Dakewe | ITMT | FDA UDI | Class II | Active |
| BioSci™ | VN | FDA UDI | Class I | Active |
| BioSci™ | ITMM | FDA UDI | Class II | Active |
| BioSci™ | ITMM | FDA UDI | Class II | Active |
| SNT Biotech | NP | FDA UDI | Class I | Active |
| Biosci™ | OP | FDA UDI | Class I | Active |
| Dakewe | ITMO | FDA UDI | Class II | Active |
| BioSci™ | VM | FDA UDI | Class I | Active |
| BioSci™ | ITMM | FDA UDI | Class II | Active |
| BioSci™ | VNO | FDA UDI | Class I | Active |
| BioSci™ | VO | FDA UDI | Class I | Active |
| Biosci™ | MS | FDA UDI | Class I | Active |
| BioSci™ | VM | FDA UDI | Class I | Active |
| SNT Biotech | OP | FDA UDI | Class I | Active |
| SNT Biotech | NP | FDA UDI | Class I | Active |
| BioSci™ | VNO | FDA UDI | Class I | Active |
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