Data / Medical devices / China / Suzhou Borage Medical Technology Co.,ltd.
Suzhou Borage Medical Technology Co.,ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 4 510(k) clearances
Suzhou Borage Medical Technology Co.,ltd. is registered with the FDA (registration 3017025817) in Suzhou Jiangsu, China. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated May 10, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017025817
- Address
- No.9 Shiheshan Road, Dongshan Town, Wuzhong District, Suzhou Jiangsu, China, 215107
- Owner or operator
- Suzhou Borage Medical Technology Co.,Ltd. (10086449)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 10, 2022
- Registered through
- 2026
- Brand names listed
- Organic Cotton Cardboard Applicator Tampon, Regular Super, Organic Cotton Tampon, Light Regular Super Super plus, TAMPON, MENSTRUAL, UNSCENTED; Model: Light, Regular, Super, Super plus, Unscented Menstrual Tampon(Light, Regular, Super, Super plus)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tampon, Menstrual, Unscented | HEB | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| May 10, 2024 | K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | HEB | Substantially Equivalent | Suzhou Borage Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 30, 2022 | K222046 | Unscented Menstrual Tampon | HEB | Substantially Equivalent | Suzhou Borage Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 20, 2019 | K191666 | Unscented W long plastic and cardboard applicator tampons | HEB | Substantially Equivalent | Ontex Bvba | accessdata.fda.gov |
| December 23, 2009 | K090819 | ONTEX TAMPON (UNSCENTED) | HEB | Substantially Equivalent | Ontex International NV | accessdata.fda.gov |
Compare with other makers
Updated May 10, 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.