Data / Medical devices / China / SMTP Medical Co., Ltd.
SMTP Medical Co., Ltd.: FDA-registered device maker in Daxing District Beijing, China, 2 510(k) clearances
SMTP Medical Co., Ltd. is registered with the FDA (registration 3021599290) in Daxing District Beijing, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 27, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021599290
- Address
- Room 2301 of Sector C and Room 2301 of Sector D, Building 1 No.29 Qingfeng West Road, Daxing Bio-medicine Industry Park, Daxing District Beijing, China, 102629
- Owner or operator
- SMTP Medical Co., Ltd. (10083856)
- Roles
- Manufacturer
- First device listed
- December 23, 2021
- Registered through
- 2026
- Brand names listed
- Ultrasonic Osteotomy Surgical System, Ultrasonic Surgical Aspirator System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ultrasonic Surgical | LFL | U | 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 |
|---|---|---|---|---|---|---|
| September 27, 2021 | K212750 | Ultrasonic Surgical Aspirator System, Model: XD880B | LFL | Substantially Equivalent | Smtp Technology Co., Ltd. | accessdata.fda.gov |
| February 19, 2021 | K201274 | Ultrasonic Osteotomy Surgical System | JDX | Substantially Equivalent | Smtp Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Ultrasonic Surgical
- All makers of Instrument, Surgical, Sonic And Accessory/Attachment
Updated September 27, 2021. 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.