Data / Medical devices / China / Suzhou Kyuan Medical Apparatus Co., Ltd.
Suzhou Kyuan Medical Apparatus Co., Ltd.: FDA-registered device maker in Suzhou City Jiangsu, China, 2 510(k) clearances
Suzhou Kyuan Medical Apparatus Co., Ltd. is registered with the FDA (registration 3004468256) in Suzhou City Jiangsu, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 3, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004468256
- Address
- Beiqiao Town, Suzhou City Jiangsu, China, 215144
- Owner or operator
- Suzhou KYUAN Medical Apparatus Co., Ltd. (10077840)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 3, 2020
- Registered through
- 2026
- Brand names listed
- Disposable Blood Lancets, Disposable Safety Lancets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 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 |
|---|---|---|---|---|---|---|
| October 3, 2022 | K221778 | Disposable Safety Lancets | FMK | Substantially Equivalent | Suzhou Kyuan Medical Apparatus Co., Ltd. | accessdata.fda.gov |
| August 17, 2022 | K220387 | Disposable Blood Lancets | QRL | Substantially Equivalent | Suzhou Kyuan Medical Apparatus Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Blade, Scalpel
Updated October 3, 2022. 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.