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Sign in to claim this brandGuangzhou Zhengkang Medical Equipment Co., Ltd
US
Last updated May 30, 2026
What Guangzhou Zhengkang Medical Equipment Co., Ltd makes
Guangzhou Zhengkang Medical Equipment Co., Ltd manufactures single-use public face masks and medical surgical masks, including a non-sterilized type sized 17.5 cm × 9.5 cm (Model: ZKM-U01). The portfolio includes generic branded masks under the ZhengKang name.
The company’s products are regulated as Class II medical devices and are listed under FDA 510(k) and UDI requirements. The manufacturer is based in the US.
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 Guangzhou Zhengkang Medical Equipment Co., Ltd primarily manufacture?
Guangzhou Zhengkang Medical Equipment Co., Ltd specializes in single-use face masks, including public face masks and medical surgical masks. Their portfolio includes both generic and branded masks under the ZhengKang name, such as the ZKM-U01 (non-sterilized type, 17.5 cm × 9.5 cm). These devices are designed for protective barrier use in healthcare and public settings.
Where is Guangzhou Zhengkang Medical Equipment Co., Ltd based?
The company is based in the United States. While the name suggests a Guangzhou origin, their operational headquarters and regulatory filings are conducted from within the US market.
How are the devices manufactured by Guangzhou Zhengkang Medical Equipment Co., Ltd classified under regulatory standards?
The company’s devices, including their public and medical surgical masks, are classified as Class II medical devices. This classification typically applies to products with moderate risk that require special controls beyond general controls to ensure safety and effectiveness.
Which regulatory registries or databases list the devices produced by Guangzhou Zhengkang Medical Equipment Co., Ltd?
The company’s devices are listed under the FDA’s 510(k) premarket notification process and comply with UDI (Unique Device Identification) requirements. These registries ensure traceability and regulatory oversight for their single-use masks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zkmedical.com
- —
- —
- [email protected]
- Phone
- +8602022036585
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 554549693
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ZhengKang | ZKM-U02 (Black) | FDA UDI | Class II | Active |
| ZhengKang | ZKM-U06 (Blue) | FDA UDI | Class II | Active |
| ZhengKang | ZKM-U01 | FDA UDI | Class II | Active |
| ZhengKang | ZKM-U05 (Black) | FDA UDI | Class II | Active |
| ZhengKang | ZKM-U03 (Blue) | FDA UDI | Class II | Active |
| ZhengKang | ZKM-U04 (White) | FDA UDI | Class II | Active |
| ZhengKang | ZKM-U07 (White) | FDA UDI | Class II | Active |
| Medical Surgical Mask | K222204 | FDA 510(k) | Class II | Active |
| Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) | K212460 | FDA 510(k) | Class II | Active |
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