Bomtech Electronics Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 4
What Bomtech Electronics Co., Ltd. makes
Bomtech Electronics Co., Ltd. manufactures the E-PEN, a medical device designed for specific diagnostic or therapeutic procedures, and the RM STAR EX with RMS Needle, a tool used in medical interventions requiring precise needle insertion. These products are intended for clinical use in controlled environments.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States, where Bomtech Electronics Co., Ltd. is based.
Catalogue
- Registry: GUDID
- Registry: GUDID
E-Pen (E-Pen) Ref K243143
Regimes: CE MDD 510(k) Registry: 510(k)RM STAR EX with RMS Needle Ref K243097
Regimes: CE MDD 510(k) Registry: 510(k)
Company details
- DUNS number
- 690464958
- [email protected]
- Phone
- +8225238295
Frequently asked questions
How many devices does Bomtech Electronics Co., Ltd. have in the registry?
The registry currently lists 4 devices for Bomtech Electronics Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bomtech Electronics Co., Ltd.'s devices?
Among its 4 most recently registered devices, Bomtech Electronics Co., Ltd. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bomtech Electronics Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Bomtech Electronics Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bomtech Electronics Co., Ltd. in the registry?
The most recently registered devices listed for Bomtech Electronics Co., Ltd. include RM STAR EX with RMS Needle, E-PEN Powered Microneedle Device and E-PEN (E-PEN).