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Wujiang City ShenLing Medical Device Co., Ltd

US

Last updated May 24, 2026

Part of Wujiang City Shen Ling Medical Device Co., Ltd.

What Wujiang City ShenLing Medical Device Co., Ltd makes

The company manufactures single-use acupuncture needles, including branded variants such as AcuZone, KSC DB PLUS, and SHENMEN, designed for traditional acupuncture procedures.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates 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 Wujiang City ShenLing Medical Device Co., Ltd manufacture?

Wujiang City ShenLing Medical Device Co., Ltd specializes in single-use acupuncture needles. These devices are specifically designed for traditional acupuncture procedures and include branded variants like AcuZone, KSC DB PLUS, and SHENMEN. The company focuses exclusively on this category of medical devices.

Where is Wujiang City ShenLing Medical Device Co., Ltd based?

The company operates in the United States. While the name suggests a location in China, the business is registered and conducts its operations within the US market.

How are the devices manufactured by Wujiang City ShenLing Medical Device Co., Ltd classified under FDA regulations?

The acupuncture needles produced by Wujiang City ShenLing Medical Device Co., Ltd are classified as Class II devices under FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Are the devices from Wujiang City ShenLing Medical Device Co., Ltd listed in any regulatory registries?

Yes, the devices manufactured by Wujiang City ShenLing Medical Device Co., Ltd are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability in the healthcare system.

Why are the acupuncture needles from Wujiang City ShenLing Medical Device Co., Ltd designed for single-use?

Single-use acupuncture needles are designed to minimize the risk of infection and contamination, which is critical in medical procedures. Reusing needles can introduce pathogens or introduce foreign materials into the patient’s body, posing serious health risks. By manufacturing single-use needles, the company adheres to best practices in infection control and patient safety.

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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LinkedIn
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Facebook
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Email
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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
654613546

Catalogue (307)

Page 1 of 7
DeviceModel / ReferenceRegistriesClassStatus
AcuZone AZ 1-22125
FDA UDI
Class IIActive
Ksc Db Plus DB-2515
FDA UDI
Class IIActive
Shenmen SM128500
FDA UDI
Class IIActive
AcuZone AZ 1-1830
FDA UDI
Class IIActive
Shenmen SM122500
FDA UDI
Class IIActive
Shenmen SM134100
FDA UDI
Class IIActive
AcuZone AZ 1-1640
FDA UDI
Class IIActive
AcuZone IN1411
FDA UDI
Class IIActive
Ksc Db Plus DB-30150
FDA UDI
Class IIActive
AcuZone IN1611
FDA UDI
Class IIActive
Shenmen SM136100
FDA UDI
Class IIActive
AcuZone PN2225
FDA UDI
Class IIActive
Ksc Db Plus DB-35150
FDA UDI
Class IIActive
Shenmen SM132100
FDA UDI
Class IIActive
Shenmen SM140050
FDA UDI
Class IIActive
AcuZone AZ 1-2250
FDA UDI
Class IIActive
AcuZone AZ 1-1440
FDA UDI
Class IIActive
Ksc Db Plus DB-3050
FDA UDI
Class IIActive
Shenmen SM232150
FDA UDI
Class IIActive
Shenmen SM122600
FDA UDI
Class IIActive
Shenmen SM230300
FDA UDI
Class IIActive
Ksc Db Plus DB-3515
FDA UDI
Class IIActive
AcuZone AZ 1-2575
FDA UDI
Class IIActive
Shenmen SM232050
FDA UDI
Class IIActive
AcuZone IN1211
FDA UDI
Class IIActive
AcuZone PN1811
FDA UDI
Class IIActive
AcuZone AZ 1-4075
FDA UDI
Class IIActive
AcuZone AZ 1-1630
FDA UDI
Class IIActive
AcuZone AZ-35100
FDA UDI
Class IIActive
AcuZone AZ-1440
FDA UDI
Class IIActive
AcuZone AZ-2240
FDA UDI
Class IIActive
AcuZone AZ 1-30125
FDA UDI
Class IIActive
AcuZone AZ-2560
FDA UDI
Class IIActive
AcuZone AZ-3050
FDA UDI
Class IIActive
Ksc Db Plus DB-40100
FDA UDI
Class IIActive
AcuZone AZ 1-1815
FDA UDI
Class IIActive
AcuZone AZ 1-2040
FDA UDI
Class IIActive
Shenmen SM126500
FDA UDI
Class IIActive
Shenmen SM128300
FDA UDI
Class IIActive
Ksc Db Plus DB-2275
FDA UDI
Class IIActive
Ksc Db Plus DB-3075
FDA UDI
Class IIActive
AcuZone AZ-25100
FDA UDI
Class IIActive
Shenmen SM130050
FDA UDI
Class IIActive
AcuZone AZ-40150
FDA UDI
Class IIActive
AcuZone AZ-2550
FDA UDI
Class IIActive
AcuZone AZ 1-2560
FDA UDI
Class IIActive
AcuZone AZ-3030
FDA UDI
Class IIActive
Shenmen SM126250
FDA UDI
Class IIActive
Ksc Db Plus DB-1815
FDA UDI
Class IIActive
Ksc Db Plus DB-2050
FDA UDI
Class IIActive

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