Sm Eng Co., Ltd.
South KoreaFDA applicant, unverified FDA
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Sm Eng Co., Ltd. makes
Sm Eng Co., Ltd. manufactures medical devices including the REXMONO and PDREX, which are likely related to peritoneal dialysis systems, as well as the REXLON, REXSIL, CRYLREX, REXSIN, and REXLENE. These products appear to serve specialized applications in surgical or orthopedic procedures, such as sutures, surgical adhesives, or tissue fixation solutions.
The company’s portfolio consists of Class II devices, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database, indicating their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Rexmono, Pdrex Ref K173779
Regimes: 510(k) Registry: 510(k)Rexlon, Rexsil Ref K161633
Regimes: 510(k) Registry: 510(k)Crylrex Ref K161629
Regimes: 510(k) Registry: 510(k)Rexsin Ref K200392
Regimes: 510(k) Registry: 510(k)Rexlene Ref K173747
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Smeng Co., Ltd. Busan · KR FEI 3008912461
Frequently asked questions
How many devices does Sm Eng Co., Ltd. have in the registry?
The registry currently lists 5 devices for Sm Eng Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sm Eng Co., Ltd.'s devices?
Among its 5 most recently registered devices, Sm Eng Co., Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Sm Eng Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sm Eng Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sm Eng Co., Ltd. in the registry?
The most recently registered devices listed for Sm Eng Co., Ltd. include REXMONO, PDREX, REXLON, REXSIL, CRYLREX and REXSIN.
Which FDA establishments are linked to Sm Eng Co., Ltd.?
1 FDA establishment is linked to Sm Eng Co., Ltd. in the registry; they are listed on the company page.