Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWujiang City ShenLing Medical Device Co., Ltd
US
Last updated May 24, 2026
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
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 654613546
Catalogue (307)
Page 5 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ksc Db Plus | DB-1640 | FDA UDI | Class II | Active |
| Shenmen | SM122400 | FDA UDI | Class II | Active |
| Shenmen | SM124300 | FDA UDI | Class II | Active |
| AcuZone | AZ-1808 | FDA UDI | Class II | Active |
| Shenmen | SM230100 | FDA UDI | Class II | Active |
| AcuZone | AZ-35150 | FDA UDI | Class II | Active |
| AcuZone | PN2615 | FDA UDI | Class II | Active |
| AcuZone | AZ 1-2015 | FDA UDI | Class II | Active |
| Ksc Db Plus | DB-35125 | FDA UDI | Class II | Active |
| Shenmen | SM130200 | FDA UDI | Class II | Active |
| Shenmen | SM126600 | FDA UDI | Class II | Active |
| AcuZone | AZ-2275 | FDA UDI | Class II | Active |
| AcuZone | AZ-2530 | FDA UDI | Class II | Active |
| AcuZone | IN1407 | FDA UDI | Class II | Active |
| AcuZone | AZ 1-35125 | FDA UDI | Class II | Active |
| Ksc Db Plus | DB-25125 | FDA UDI | Class II | Active |
| Shenmen | SM124400 | FDA UDI | Class II | Active |
| Ksc Db Plus | DB-2250 | FDA UDI | Class II | Active |
| Ksc Db Plus | DB-2240 | FDA UDI | Class II | Active |
| AcuZone | AZ 1-3550 | FDA UDI | Class II | Active |
| AcuZone | AZ 1-1850 | FDA UDI | Class II | Active |
| Shenmen | SM122300 | FDA UDI | Class II | Active |
| AcuZone | PN1812 | FDA UDI | Class II | Active |
| AcuZone | AZ-1830 | FDA UDI | Class II | Active |
| Ksc Db Plus | DB-1415 | FDA UDI | Class II | Active |
| AcuZone | IN1605 | FDA UDI | Class II | Active |
| AcuZone | IN1207 | FDA UDI | Class II | Active |
| AcuZone | PN2010 | FDA UDI | Class II | Active |
| Shenmen | SM124100 | FDA UDI | Class II | Active |
| AcuZone | AZ-3560 | FDA UDI | Class II | Active |
| Shenmen | SM230400 | FDA UDI | Class II | Active |
| Shenmen | SM124500 | FDA UDI | Class II | Active |
| AcuZone | PN2016 | FDA UDI | Class II | Active |
| Ksc Db Plus | DB-30100 | FDA UDI | Class II | Active |
| AcuZone | AZ-3540 | FDA UDI | Class II | Active |
| Shenmen | SM230150 | FDA UDI | Class II | Active |
| AcuZone | AZ-2575 | FDA UDI | Class II | Active |
| AcuZone | PN2015 | FDA UDI | Class II | Active |
| AcuZone | AZ-3040 | FDA UDI | Class II | Active |
| AcuZone | AZ-2060 | FDA UDI | Class II | Active |
| AcuZone | AZ 1-1430 | FDA UDI | Class II | Active |
| Shenmen | SM132250 | FDA UDI | Class II | Active |
| Ksc Db Plus | DB-40125 | FDA UDI | Class II | Active |
| Shenmen | SM134050 | FDA UDI | Class II | Active |
| AcuZone | AZ 1-4050 | FDA UDI | Class II | Active |
| AcuZone | IN1205 | FDA UDI | Class II | Active |
| AcuZone | PN2025 | FDA UDI | Class II | Active |
| AcuZone | PN2013 | FDA UDI | Class II | Active |
| Ksc Db Plus | DB-3575 | FDA UDI | Class II | Active |
| AcuZone | AZ-1430 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.