Data / Medical devices / China / Jiangsu Jiyuan Medical Technology Co., Ltd.
Jiangsu Jiyuan Medical Technology Co., Ltd.: FDA-registered device maker in Taizhou Jiangsu, China, 2 510(k) clearances
Jiangsu Jiyuan Medical Technology Co., Ltd. is registered with the FDA (registration 3021023673) in Taizhou Jiangsu, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021023673
- Address
- No. 48 CECEP(Taizhou) Environmental Protection Technology Industry Park,No.59 Meilan Road,Hailing District, Taizhou Jiangsu, China, 225300
- Owner or operator
- Jiangsu Jiyuan Medical Technology Co., Ltd. (10083005)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 20, 2021
- Registered through
- 2026
- Brand names listed
- ARMI® Endoscopic Video Image Processor, ARMI® Single-Use Hysteroscope, Disposable Endoscopic Scissors, Disposable endoscopic forceps, Medical Endoscope Image Processing System, WiScope® Single-Use Digital Hysteroscope, Model: OTU-HJ01
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Forceps, Biopsy, Gynecological | HFB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Hysteroscope Accessories | NWW | 1 | Complaint file establishment, Manufacturer, Specification developer | 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 18, 2025 | K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) | HIH | Substantially Equivalent | Jiangsu Jiyuan Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 1, 2021 | K210270 | Medical Endoscope Image Processing System | HIH | Substantially Equivalent | Jiangsu Jiyuan Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Hysteroscope (And Accessories)
- All makers of Hysteroscope Accessories
- All makers of Forceps, Biopsy, Gynecological
Updated December 18, 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.