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Sign in to claim this brandShenzhen Uni-medica Technology Co., Ltd.
China·CN-MF-000022946
Last updated September 18, 2026
What Shenzhen Uni-medica Technology Co., Ltd. makes
Shenzhen Uni-medica Technology Co., Ltd. manufactures diagnostic immunoassay analyzers, including fluorescent immunoanalyzers, and automated nucleic acid extraction systems. These devices are designed for laboratory use in detecting antibodies, antigens, and nucleic acids in clinical samples, supporting infectious disease testing and immunology diagnostics.
The company’s products are classified as Class A medical devices under EU regulations and are listed in the EUDAMED database. The manufacturer is based in China and adheres to relevant regulatory requirements for in vitro diagnostic devices.
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 Uni-medica Technology Co., Ltd. manufacture?
Shenzhen Uni-medica Technology Co., Ltd. specializes in diagnostic devices, including fluorescent immunoanalyzers and automated nucleic acid extraction systems. These devices are primarily used in laboratory settings to detect antibodies, antigens, and nucleic acids in clinical samples, aiding in infectious disease testing and immunology diagnostics.
Where is Shenzhen Uni-medica Technology Co., Ltd. based?
The company is headquartered in Shenzhen, China. This location reflects its operational base for manufacturing, research, and regulatory compliance related to its diagnostic devices.
Are Shenzhen Uni-medica Technology Co., Ltd.’s devices listed in any regulatory registries?
Yes, the company’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This listing helps ensure transparency and traceability of Class A devices under EU regulatory requirements.
How are Shenzhen Uni-medica Technology Co., Ltd.’s devices classified under EU regulations?
Shenzhen Uni-medica Technology Co., Ltd.’s devices fall under Class A classification in the EU. This classification is typically assigned to low-risk in vitro diagnostic devices, such as certain immunoassays and nucleic acid extraction systems, based on their intended use and risk profile.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- Block 6th,LiuXian Culture Park, Shenzhen, China
- Website
- www.uni-medica.com
- —
- —
- [email protected]
- Phone
- +86-755-86505501
- PRRC Contact
- Peng Zhang
- EUDAMED SRN
- CN-MF-000022946
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Uni-medica | / | EUDAMED | Class A | Active |
| Uni-medica | 16.02.003.08 | EUDAMED | Class A | Active |
| Uni-medica | 15.09.001.02 | EUDAMED | Class A | Active |
| Uni-medica Fluorescent Immunoanalyzer | UM-IF 100 | EUDAMED | Class A | Active |
| Uni-medica | / | EUDAMED | Class A | Active |
| Automatic Nucleic Acid System | NFast 9601 | EUDAMED | Class A | Active |
| Automatic Nucleic Acid System | NFast 9602 | EUDAMED | Class A | Active |
| Uni-medica | / | EUDAMED | Class A | Active |
| Uni-medica | / | EUDAMED | Class A | Active |
| Uni-medica | - | EUDAMED | Class A | Active |
| Uni-medica | / | EUDAMED | Class A | Active |
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