Sejong Healthcare Co., Ltd.
South KoreaFDA applicant, unverified FDA FEI 3017398283
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Sejong Healthcare Co., Ltd. makes
Sejong Healthcare Co., Ltd. manufactures the SEJONG Surgical Gown Soft, which is a Class II medical device.
The company is based in the US and its products are listed in the FDA 510(k) registry.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
SEJONG Surgical Gown Soft Ref K220435
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3017398283
- DUNS number
- 694075802
- Address
- 1502-1 Tongil-ro, Paju-eup, Paju Gyeonggi
Frequently asked questions
How many devices does Sejong Healthcare Co., Ltd. have in the registry?
The registry currently lists 5 devices for Sejong Healthcare Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sejong Healthcare Co., Ltd.'s devices?
Among its 5 most recently registered devices, Sejong Healthcare Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sejong Healthcare Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sejong Healthcare Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sejong Healthcare Co., Ltd. in the registry?
The most recently registered devices listed for Sejong Healthcare Co., Ltd. include SEJONG Surgical Gown Soft GSGW972, SEJONG Surgical Gown Soft GSGW975, SEJONG Surgical Gown Soft GSGW973 and SEJONG Surgical Gown Soft GSGW971.