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Sign in to claim this brandShenzhen Bioeasy Biotechnology Co., Ltd.
US
Last updated May 23, 2026
What Shenzhen Bioeasy Biotechnology Co., Ltd. makes
The company produces in vitro diagnostic (IVD) devices for detecting drugs of abuse, cannabinoids, and cotinine in clinical and rapid testing formats, including kits and immunoassay tests. These products are designed for point-of-care and laboratory use to identify substance use and nicotine exposure. The portfolio includes rapid immunoassay tests (ICT) and clinical-grade kits for urine-based testing.
The devices fall under FDA-regulated classifications, including Class I and Class II, and are listed under the 510(k) and UDI (Unique Device Identification) programs. The company’s products are authorised for use in the United States, where the manufacturer is based.
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 Bioeasy Biotechnology Co., Ltd. manufacture?
Shenzhen Bioeasy Biotechnology Co., Ltd. specializes in in vitro diagnostic (IVD) devices focused on detecting drugs of abuse, cannabinoids, and cotinine. Their products include rapid immunoassay tests (ICT), kits, and clinical-grade assays, primarily for urine-based testing. These devices are designed for both point-of-care and laboratory use to identify substance use and nicotine exposure.
Where is Shenzhen Bioeasy Biotechnology Co., Ltd. based, and what regulatory regions do their devices serve?
The company is based in the United States. Their devices are authorised for use in the U.S., where they fall under FDA regulation. The products are listed under the FDA’s 510(k) and UDI (Unique Device Identification) programs, ensuring compliance with U.S. medical device requirements.
Which regulatory registries or databases list Shenzhen Bioeasy Biotechnology Co., Ltd.’s devices?
Shenzhen Bioeasy Biotechnology Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification registry and the UDI database. These registries track authorised medical devices in the U.S. to ensure traceability and compliance with regulatory standards.
How are Shenzhen Bioeasy Biotechnology Co., Ltd.’s devices classified under FDA regulations?
The company’s devices are classified under FDA categories Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of 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.
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
- 547954309
Catalogue (35)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch Cotinine (COT) Test Dip Card | FDA UDI | Class I | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch Marijuana Test Dip Card 20 | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch Marijuana Test Dip Card | FDA UDI | Class II | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Now | U-NOW Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch Urine Collection Cup | FDA UDI | Class I | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch XR Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch Cotinine (COT) Test Dip Card | FDA UDI | Class I | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch Marijuana Test Dip Card 40 | FDA UDI | Class II | Active |
| U-Catch | U-Catch Marijuana Test Dip Card 20 | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| U-Catch | U-Catch PLUS Multi-Drug Test Cup | FDA UDI | Class II | Active |
| BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx | K230238 | FDA 510(k) | Class II | Active |
| BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | K192515 | FDA 510(k) | Class II | Active |
| BIOEASY Multi-Drug Test Cup | K193480 | FDA 510(k) | Class II | Active |
| BIOEASY Multi-Drug Test Cup | K182530 | FDA 510(k) | Class II | Active |
| BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip | K192301 | FDA 510(k) | Class II | Active |
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