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Sign in to claim this brandWhat Wuhan Greentek Pty Ltd. makes
Wuhan Greentek Pty Ltd. manufactures single-use electroencephalographic (EEG) electrode caps and reusable electrocardiographic (ECG) lead sets. These products are designed for non-invasive monitoring of brain activity and cardiac electrical signals, respectively, in clinical and diagnostic settings.
The company’s devices are classified as Class II under regulatory frameworks, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
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 Wuhan Greentek Pty Ltd. manufacture?
Wuhan Greentek Pty Ltd. specializes in two primary device categories: single-use electroencephalographic (EEG) electrode caps, which are used for non-invasive brain activity monitoring, and reusable electrocardiographic (ECG) lead sets, designed for cardiac electrical signal monitoring. These devices are intended for clinical and diagnostic applications.
Where is Wuhan Greentek Pty Ltd. based?
The company operates from the United States, as indicated in its regulatory documentation. This location is relevant for compliance and distribution purposes under applicable regulatory frameworks.
Which regulatory registries list Wuhan Greentek Pty Ltd.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, particularly for Class II devices, which require such documentation.
How are Wuhan Greentek Pty Ltd.’s devices classified under regulatory standards?
The company’s devices are classified as Class II under regulatory frameworks. This classification typically applies to devices that pose moderate risks and require special controls beyond general controls to ensure safety and effectiveness, such as EEG and ECG monitoring tools.
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
- 530267329
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Greentek | AM-MD15-13C1 | FDA UDI | Class II | Active |
| Greentek | AM-MD15-23ST | FDA UDI | Class II | Active |
| Greentek | Flex-cap BM-FN03-13C1 | FDA UDI | Class II | Active |
| Greentek | Flex-cap BM-FC03-23C1 | FDA UDI | Class II | Active |
| Greentek | Flex-cap BM-FA03-23C1 | FDA UDI | Class II | Active |
| Greentek | Flex-Cap BM-FA01-23ST | FDA UDI | Class II | Active |
| Greentek | AM-MD15-23C1 | FDA UDI | Class II | Active |
| Greentek | Flex-Cap BM-FC01-23ST | FDA UDI | Class II | Active |
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