Hubei Xinxin Non-Woven Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
Catalogue
- Registry: GUDID
- Registry: GUDID
AAMI4 Isolation Gown Ref K214116
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Surgical Masks Ref K212120
Regimes: 510(k) Registry: 510(k)AAMI3 Isolation Gown Ref K213832
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 544358965
FDA establishments
- Hubei Xinxin Non-Woven Co., Ltd Xiantao Hubei · CN FEI 3011547453
Frequently asked questions
How many devices does Hubei Xinxin Non-Woven Co., Ltd. have in the registry?
The registry currently lists 6 devices for Hubei Xinxin Non-Woven Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hubei Xinxin Non-Woven Co., Ltd.'s devices?
Among its 6 most recently registered devices, Hubei Xinxin Non-Woven Co., Ltd. has devices listed in FDA 510(k) (4 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hubei Xinxin Non-Woven Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Hubei Xinxin Non-Woven Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hubei Xinxin Non-Woven Co., Ltd. in the registry?
The most recently registered devices listed for Hubei Xinxin Non-Woven Co., Ltd. include Sterile Level 3 Surgical Gown M4025, Reinforced Sterile Level 4 Surgical Gown GM4025, AAMI4 Isolation Gown and Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025).
Which FDA establishments are linked to Hubei Xinxin Non-Woven Co., Ltd.?
1 FDA establishment is linked to Hubei Xinxin Non-Woven Co., Ltd. in the registry; they are listed on the company page.