Data / Medical devices / China / Neo Modulus (suzhou) Medical Sci-Tech Co., Ltd.
Neo Modulus (suzhou) Medical Sci-Tech Co., Ltd.: FDA-registered device maker in Suzhou City Jiangsu, China, 1 510(k) clearance
Neo Modulus (suzhou) Medical Sci-Tech Co., Ltd. is registered with the FDA (registration 3043657402) in Suzhou City Jiangsu, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043657402
- Address
- Room 301, 302, Building 11, No. 8 Jinfeng Road, Suzhou City Jiangsu, China, 215163
- Owner or operator
- Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. (10095056)
- Roles
- Manufacturer
- First device listed
- January 19, 2026
- Registered through
- 2026
- Brand names listed
- Neocirrus Augmented Gingival Matrix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 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 5, 2025 | K250512 | Augmented Gingival Matrix | NPL | Substantially Equivalent | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 5, 2025. 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.