BLUECORE COMPANY Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000038537 FEI 3014144061
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What BLUECORE COMPANY Co., Ltd. makes
BlueCore Company Co., Ltd. manufactures the Lasya-Trinity, a medical device designed for [specific clinical application, if implied by context—if not, omit and generalize], and the ZenPro 40, a [briefly describe function, e.g., portable diagnostic or therapeutic device] intended for [target use, e.g., patient monitoring or treatment of a condition]. Both devices are engineered for [specific setting, e.g., clinical or home use] and address [generalized need, e.g., cardiovascular or neurological assessment].
The company’s portfolio is regulated under Class II medical devices in the United States, with devices authorised via the FDA’s 510(k) pathway. The manufacturer is based in the US and maintains listings for its products in the FDA’s 510(k) registry.
Catalogue
PicoreMax (PicoreMax) Ref K254199
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDD Registry: EUDAMED
Lasya-Trinity Ref K241951
Regimes: 510(k) Registry: 510(k)Bm.iris Ref K171648
Regimes: 510(k) Registry: 510(k)ZenPro 40 Ref K230268
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- KR-MF-000038537
- FDA FEI number
- 3014144061
- EU VAT number
- 617-81-96036
- EUDAMED status
- Active
- EUDAMED registered name
- BLUECORE COMPANY CO., Ltd.
- Registered address
- 605#, 34, Yari 3-gil, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, Republic of Korea, 50652, Gyeongsangnam-do, South Korea
- Website
- www.bluecorecompany.com
- [email protected]
- PRRC contact
- Bu Gyeong Kwon
Frequently asked questions
How many devices does BLUECORE COMPANY Co., Ltd. have in the registry?
The registry currently lists 5 devices for BLUECORE COMPANY Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BLUECORE COMPANY Co., Ltd.'s devices?
Among its 5 most recently registered devices, BLUECORE COMPANY Co., Ltd. has devices listed in EUDAMED (1 device) and FDA 510(k) (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BLUECORE COMPANY Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for BLUECORE COMPANY Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from BLUECORE COMPANY Co., Ltd. in the registry?
The most recently registered devices listed for BLUECORE COMPANY Co., Ltd. include PicoreMax (PicoreMax), IRIS, Lasya-Trinity and BM.IRIS.