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Suzhou Haowei Medical Technology Co., Ltd.

US

Last updated May 23, 2026

What Suzhou Haowei Medical Technology Co., Ltd. makes

Suzhou Haowei Medical Technology Co., Ltd. manufactures UniPearls® Embolic Microspheres, a type of embolic agent used in vascular embolization procedures to occlude blood vessels.

The company’s embolic microspheres are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer 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 Suzhou Haowei Medical Technology Co., Ltd. manufacture?

Suzhou Haowei Medical Technology Co., Ltd. specializes in embolic microspheres, specifically the UniPearls® Embolic Microspheres. These devices are designed for vascular embolization, a procedure used to block blood vessels to treat conditions like arteriovenous malformations or tumors.

Where is Suzhou Haowei Medical Technology Co., Ltd. based?

The company is headquartered in the United States. While the name suggests a Chinese origin, the business operations and regulatory filings are conducted through its US-based entity.

How are Suzhou Haowei Medical Technology Co., Ltd.’s devices classified under FDA regulations?

UniPearls® Embolic Microspheres fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Which regulatory registries or pathways list Suzhou Haowei Medical Technology Co., Ltd.’s devices?

The UniPearls® Embolic Microspheres are listed via the FDA’s 510(k) pathway, which demonstrates that the device is substantially equivalent to a legally marketed predicate device. This pathway is commonly used for Class II devices requiring pre-market notification.

AI-generated from registry data and not verified by a human reviewer.

Information

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US
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Catalogue (52)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Mingwei MWTX-A73-0.6/1.2-150
FDA UDI
Class IActive
Mingwei MWTX-A77K-0.7/1.3-150S
FDA UDI
Class IActive
Mingwei MWTX76-0.6/1.2-150
FDA UDI
Class IActive
Mingwei MWTX73-0.6/1.2-150H
FDA UDI
Class IActive
Mingwei MWHX7420B
FDA UDI
Class IActive
Mingwei MWHX7110B
FDA UDI
Class IActive
Mingwei MWHX7220B
FDA UDI
Class IActive
Mingwei MWHX7520A
FDA UDI
Class IActive
Mingwei MWTX75-0.6/1.2-150
FDA UDI
Class IActive
Mingwei MWTX74-0.6/1.2-150
FDA UDI
Class IActive
Mingwei MWTX-A71K-0.6/1.5-125S
FDA UDI
Class IActive
Mingwei MWTX78-0.6/1.5-125
FDA UDI
Class IActive
Mingwei MWHX7010A
FDA UDI
Class IActive
Mingwei MWHX7210A
FDA UDI
Class IActive
Mingwei MWTX71-0.6/1.2-125S
FDA UDI
Class IActive
Mingwei MWTX77-0.7/1.3-130
FDA UDI
Class IActive
Mingwei MWTX-A104-0.6/1.2-150H
FDA UDI
Class IActive
Mingwei MWHX7810B
FDA UDI
Class IActive
Mingwei MWTX64-0.8/1.3-130
FDA UDI
Class IActive
Mingwei MWHX7810A
FDA UDI
Class IActive
Mingwei MWHX7010B
FDA UDI
Class IActive
Mingwei MWTX64-0.6/1.3-130H
FDA UDI
Class IActive
Mingwei MWHX6410A
FDA UDI
Class IActive
Mingwei MWHX7620B
FDA UDI
Class IActive
Mingwei MWHX7360A
FDA UDI
Class IActive
Mingwei MWTX77-0.7/1.3-130
FDA UDI
Class IActive
Mingwei MWTX-A70K-1.0/2.0-125S
FDA UDI
Class IActive
Mingwei MWHX7620A
FDA UDI
Class IActive
Mingwei MWTX-A64-0.3/0.6-125
FDA UDI
Class IActive
Mingwei MWHX6411A
FDA UDI
Class IActive
Mingwei MWHX7520B
FDA UDI
Class IActive
Mingwei MWHX6460A
FDA UDI
Class IActive
Mingwei MWTX64-0.6/1.3-130
FDA UDI
Class IActive
Mingwei MWHX7220A
FDA UDI
Class IActive
Mingwei MWHX7360B
FDA UDI
Class IActive
Mingwei MWTX77-0.7/1.3-130
FDA UDI
Class IActive
Mingwei MWTX64-0.3/0.6-130
FDA UDI
Class IActive
Mingwei MWTX72-1.0/2.0-150
FDA UDI
Class IActive
Mingwei MWTX79-0.6/1.2-150
FDA UDI
Class IActive
Mingwei MWTX71-0.6/1.2-125
FDA UDI
Class IActive
Mingwei MWHX7210B
FDA UDI
Class IActive
Mingwei MWHX6412A
FDA UDI
Class IActive
Mingwei MWHX7110A
FDA UDI
Class IActive
Mingwei MWTX73-0.6/1.2-150
FDA UDI
Class IActive
Mingwei MWTX70-1.0/2.0-125
FDA UDI
Class IActive
Mingwei MWTX77-0.7/1.3-135
FDA UDI
Class IActive
Mingwei MWHX7420A
FDA UDI
Class IActive
Mingwei MWTX72-1.0/2.0-125
FDA UDI
Class IActive
Mingwei MWTX100-0.6/1.2-150H
FDA UDI
Class IActive
Mingwei MWTX71-0.6/1.5-125S
FDA UDI
Class IActive

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FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

  • Mingwei Medical Technology(suzhou) Co., Ltd Suzhou Jiangsu · CN FEI 3017616637
  • Suzhou Haowei Medical Technology Co., Ltd. Suzhou Jiangsu · CN FEI 3033841272