Data / Medical devices / China / Changzhou Sifary Medical Technology Co., Ltd.
Changzhou Sifary Medical Technology Co., Ltd.: FDA-registered device maker in Changzhou Jiangsu, China, 7 510(k) clearances
Changzhou Sifary Medical Technology Co., Ltd. is registered with the FDA (registration 3016875543) in Changzhou Jiangsu, China. It lists 14 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016875543
- Address
- No. 26 Yandanghe Road, Xinbei District, Changzhou Jiangsu, China, 213000
- Owner or operator
- Changzhou Sifary Medical Technology Co., Ltd. (10074229)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 3, 2021
- Registered through
- 2027
- Brand names listed
- Apex Locator, FindPex, CuringPen Dental Curing Light, Dental Cone-beam Computed Tomography (model: FinScan F350), Dental Curing light (Model: Kulzer Translux Cure), Dental Sensors NanoPix1, NanoPix2, NanoPix1.5, Brand: Eighteeth, Dental Sensors V-Sensor1, V-Sensor2, E-Connect S Endo Motor With Built-In Apex Locator, E-FLEX, E-FLEX S, E-FLEX BLUE, E-FLEX GOLD, E-FLEX EDGE, E-FLEX RT, E-FLEX REC, E-FLEX ONE, E-FLEX MINI and more
Devices it lists
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 14, 2026 | K260795 | Hand-held Dental X-ray System (HyperLight-M) | EHD | Substantially Equivalent | Changzhou Sifary Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 8, 2026 | K252224 | Apex Locator (FindPex) | LQY | Substantially Equivalent | Changzhou Sifary Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 9, 2025 | K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | OAS | Substantially Equivalent | Changzhou Finno Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 1, 2023 | K232068 | HyperLight Portable X-ray Unit | EHD | Substantially Equivalent | Changzhou Sifary Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 23, 2022 | K221152 | CuringPen Dental Curing Light | EBZ | Substantially Equivalent | Changzhou Sifary Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 11, 2022 | K220422 | Dental sensors NanoPix1, NanoPix2 | MUH | Substantially Equivalent | Iray Technology Taicang , Ltd. | accessdata.fda.gov |
| January 29, 2021 | K201993 | E-connect S Endo Motor with built-in Apex Locator | EKX | Substantially Equivalent | Changzhou Sifary Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Loupe, Diagnostic/Surgical
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Microscope, Surgical
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of File, Pulp Canal, Endodontic
Updated September 14, 2026. 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.