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Sign in to claim this brandShantou Wealy Medical Instrument Co., Ltd.
US
Last updated May 30, 2026
What Shantou Wealy Medical Instrument Co., Ltd. makes
The company manufactures metered-delivery hypodermic syringes and reusable ENFit oral/enteral syringes, designed for precise fluid administration in medical and clinical settings.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in 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 Shantou Wealy Medical Instrument Co., Ltd. manufacture?
Shantou Wealy Medical Instrument Co., Ltd. specializes in two primary device categories: metered-delivery hypodermic syringes and reusable ENFit oral/enteral syringes. These devices are engineered for accurate fluid administration in medical and clinical environments, ensuring precise dosing and compatibility with specific medical applications.
Where is Shantou Wealy Medical Instrument Co., Ltd. based?
The company is headquartered in the United States. This location allows it to align with regulatory frameworks and supply chains relevant to the US medical device market.
Which regulatory registries list devices manufactured by Shantou Wealy Medical Instrument Co., Ltd.?
Devices produced by Shantou Wealy Medical Instrument Co., Ltd. are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers and regulators.
How are devices from Shantou Wealy Medical Instrument Co., Ltd. classified under FDA regulations?
The company’s devices, including metered-delivery hypodermic syringes and reusable ENFit oral/enteral syringes, fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness.
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
- 545570186
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Wealy | 1ml 25Gx1" | FDA UDI | Class II | Active |
| Wealy | 3ml 25Gx1" | FDA UDI | Class II | Active |
| Wealy | 3ml 23Gx1" | FDA UDI | Class II | Active |
| Wealy | 60ml | FDA UDI | Class II | Active |
| Wealy | 3ml 23Gx1 1/4" | FDA UDI | Class II | Active |
| Wealy | 10ml 22Gx1 1/2" | FDA UDI | Class II | Active |
| Wealy | 1ml 27Gx1/2" | FDA UDI | Class II | Active |
| Wealy | 20ml | FDA UDI | Class II | Active |
| Wealy | 3ml 25Gx5/8" | FDA UDI | Class II | Active |
| Wealy | 1ml 25Gx5/8" | FDA UDI | Class II | Active |
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