Suzhou Borage Medical Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000059934
- Devices
- 7
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Suzhou Borage Medical Technology Co., Ltd. makes
Suzhou Borage Medical Technology Co., Ltd. manufactures unscented menstrual tampons and organic cotton tampons, including variants with PESCVcord material. These products are designed for feminine hygiene applications.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the US.
Catalogue
Cleaning wipes Ref 150*100 mm
Regimes: CE MDR Registry: EUDAMED- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Unscented Menstrual Tampon Ref K222046
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- CN-MF-000059934
- DUNS number
- 541550629
- EUDAMED status
- Active
- EUDAMED registered name
- Suzhou Borage Medical Technology Co., Ltd.
- EUDAMED abbreviated name
- Suzhou Borage
- Registered address
- No. 9, Shiheshan Road, Dongshan Town,Wuzhong District, Suzhou City, Jiangsu Province, China, 215107, Suzhou, China
- [email protected]
- PRRC contact
- Dandan Wang
FDA establishments
- Suzhou Borage Medical Technology Co., Ltd. Suzhou Jiangsu · CN FEI 3017025817
Frequently asked questions
How many devices does Suzhou Borage Medical Technology Co., Ltd. have in the registry?
The registry currently lists 7 devices for Suzhou Borage Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Borage Medical Technology Co., Ltd.'s devices?
Among its 7 most recently registered devices, Suzhou Borage Medical Technology Co., Ltd. has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Suzhou Borage Medical Technology Co., Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Suzhou Borage Medical Technology Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suzhou Borage Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Suzhou Borage Medical Technology Co., Ltd. include Cleaning wipes, Borage Medical Regular, Unscented Menstrual Tampon and Organic Cotton Tampon; Organic Cotton PESCVcord Tampon.
Which FDA establishments are linked to Suzhou Borage Medical Technology Co., Ltd.?
1 FDA establishment is linked to Suzhou Borage Medical Technology Co., Ltd. in the registry; they are listed on the company page.