Smc
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000018470 FEI 3011221234
- Devices
- 352
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Smc makes
SMC manufactures medical devices including the BS02004025, a Class IIa product designed for specific clinical applications. Their portfolio includes items such as surgical instruments, diagnostic tools, and related accessories used in medical procedures.
The company’s devices are regulated under EU medical device directives and are listed in the EUDAMED registry. Their products fall under Class IIa classification, adhering to European Union regulatory standards. The manufacturer is based in South Korea.
Catalogue
Search and filter all 352 devicesShowing 1-50 of 352
Company details
- EUDAMED SRN
- KR-MF-000018470
- FDA FEI number
- 3011221234
- DUNS number
- 689846232
- EUDAMED status
- Active
- EUDAMED registered name
- SMC
- Registered address
- 30, Daeposandan-ro, Yangchon-eup, 10048, Gimpo-si, South Korea
- [email protected]
- PRRC contact
- Min-Woo Lee
Frequently asked questions
How many devices does SMC have in the registry?
The registry currently lists 352 devices for SMC. Devices recorded under merged duplicate company entries are counted once.
Which registries list SMC's devices?
Among its 50 most recently registered devices, SMC has devices listed in EUDAMED (50 devices).
What risk classes do SMC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SMC's devices are Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from SMC in the registry?
The most recently registered devices listed for SMC include SMC ACUPUNCTURE NEEDLE(ALTERNATIVE NAME_ BADIM ACUPUNTURE NEEDLE).