Data / Medical devices / China / Origyn Medical Technology (hangzhou) Co., Ltd
Origyn Medical Technology (hangzhou) Co., Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance
Origyn Medical Technology (hangzhou) Co., Ltd is registered with the FDA (registration 3028536560) in Hangzhou Zhejiang, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 26, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3028536560
- Address
- 688 Bin'an Road Building 2E, 2/F, Room 243, Hangzhou Zhejiang, China, 310051
- Owner or operator
- OriGyn Medical Technology (Hangzhou) Co., Ltd (10091314)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 21, 2024
- Registered through
- 2026
- Brand names listed
- Biopsy forceps, ClearVision Single Use Hysteroscope & Image Processing System, Grasping Forceps, Scissors, Separating forceps
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Hysteroscope Accessories | NWW | 1 | 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 |
|---|---|---|---|---|---|---|
| July 26, 2024 | K240401 | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) | HIH | Substantially Equivalent | Origyn Medical Technology (Hangzhou) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 26, 2024. 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.