Jiangmen Sure&Me Medical Product Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 3
What Jiangmen Sure&Me Medical Product Co., Ltd. makes
Jiangmen Sure&Me Medical Product Co., Ltd. manufactures single-use surgical and medical face masks designed for healthcare settings. Their portfolio includes models like the Sure & Me series and the Medical Surgical Mask (MP002-5 and MP002-6), which are intended for patient and clinician protection during medical procedures.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) and UDI registries. The company operates with a presence in the United States, adhering to applicable medical device regulations for respiratory protection products.
Catalogue
- Registry: GUDID
- Registry: GUDID
Medical Surgical Mask-Model MP002-5, MP002-6 Ref K202577
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 544326854
Frequently asked questions
How many devices does Jiangmen Sure&Me Medical Product Co., Ltd. have in the registry?
The registry currently lists 3 devices for Jiangmen Sure&Me Medical Product Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jiangmen Sure&Me Medical Product Co., Ltd.'s devices?
Among its 3 most recently registered devices, Jiangmen Sure&Me Medical Product Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Jiangmen Sure&Me Medical Product Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Jiangmen Sure&Me Medical Product Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Jiangmen Sure&Me Medical Product Co., Ltd. in the registry?
The most recently registered devices listed for Jiangmen Sure&Me Medical Product Co., Ltd. include Sure & Me MP002-6, Sure & Me MP002-5 and Medical Surgical Mask-Model MP002-5, MP002-6.