Suzhou Borage Medical Technology Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 1 device type, 2 clearances.
Suzhou Borage Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Tampon, Menstrual, Unscented. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | SUZHOU BORAGE MEDICAL TECHNOLOGY CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017025817 |
| FEI number | 3017025817 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 苏州宝丽洁医疗科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No.9 Shiheshan Road, Dongshan Town, Wuzhong District |
| Postal code | 215107 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Tampon, Menstrual, Unscented | Class 2 | Unscented Menstrual Tampon(Light, Regular, Super, Super plus), Organic Cotton Cardboard Applicator Tampon, Regular Super, TAMPON, MENSTRUAL, UNSCENTED; Model: Light, Regular, Super, Super plus, Organic Cotton Tampon, Light Regular Super Super plus | 2022 | 10 |
Clearances
2 clearances name Suzhou Borage Medical Technology Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240708 | 2024-05-10 | HEB | Traditional | This company |
| K222046 | 2022-09-30 | HEB | Traditional | This company |
| K191666 | 2019-12-20 | HEB | Traditional | Ontex Bvba |
| K090819 | 2009-12-23 | HEB | Abbreviated | Ontex BV |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 1000 |
| Factory area | 118000 |
| Main products | Wet wipes, Baby care wipes, Feminine care wipes, Adult care wipes, Disinfection wipes |
| Certifications | ISO 9001, ISO 14001, ISO 45001, SGS, National High-tech Enterprise |
| Export markets | Global (2000+ brands) |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.