Data / Medical devices / China / Wujiang City Shen Ling Medical Device Co.,Ltd.
Wujiang City Shen Ling Medical Device Co.,Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Wujiang City Shen Ling Medical Device Co.,Ltd. is registered with the FDA (registration 9612390) in Suzhou Jiangsu, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 12, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612390
- FEI number
- 3003255801
- Address
- East of Building FS-02, No. 807 West Ganquan Road, Jiangling Street Wujiang District, Suzhou Jiangsu, China, 215200
- Owner or operator
- Wujiang City Shen Ling Medical Device Co., Ltd. (9042446)
- Roles
- Manufacturer
- First device listed
- April 22, 2008
- Registered through
- 2026
- Brand names listed
- 540 Derma Roller, Beard Roller, CARBO, Energy Flo, Peace, Acubest, New Meridian, AA, TAIYI TCM, KSC DB Plus Acupuncture needles, Intradermal needle,, Derma Pen, Derma Roller, Derma Stamp, Hydra Needle, Hydra Roller and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | 1 | Manufacturer | accessdata.fda.gov |
| Device, Pressure Applying | KNM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2000 | K002411 | SHENLING ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Shenling Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Acupuncture, Single Use
- All makers of Brush, Dermabrasion, Manual
- All makers of Device, Pressure Applying
Updated December 12, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.