NGeneBio Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000042887
- Devices
- 9
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
HEMEaccuTest DNA Ref NGB121V-048
CE IVDD EUDAMEDSOLIDaccuTest DNA Ref NGB131V-048
CE IVDD EUDAMEDHEMEaccuTest DNA Ref NGB121V-096
CE IVDD EUDAMEDNGeneAnalySys Ref NGB312VWW
CE IVDD EUDAMEDONCOaccuPanel Ref NGB162V-060
CE IVDD EUDAMEDSOLIDaccuTest DNA Ref NGB131V-096
CE IVDD EUDAMEDBRCAaccuTest PLUS Ref NGB112V-024
CE IVDD EUDAMEDBRCAaccuTest PLUS Ref NGB112V-012
CE IVDD EUDAMEDBRCAaccuTest™ PLUS Ref NGB112V
CE IVDR EUDAMED
Company details
- EUDAMED SRN
- KR-MF-000042887
- EUDAMED status
- Active
- EUDAMED registered name
- NGeneBio Co., Ltd.
- EUDAMED abbreviated name
- NGB
- Registered address
- 288, 3F #303, Daerung-Post-tower 1, Digital-ro, 08390, Guro-gu, Seoul, South Korea
- Website
- www.ngenebio.com/en/index.asp
- linkedin.com/company/ngenebio
- [email protected]
- Phone
- +82 10 6302 9509
- PRRC contact
- Keunsook Lee
Frequently asked questions
How many devices does NGeneBio Co., Ltd. have in the registry?
The registry currently lists 9 devices for NGeneBio Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list NGeneBio Co., Ltd.'s devices?
Among its 9 most recently registered devices, NGeneBio Co., Ltd. has devices listed in EUDAMED (9 devices).
What risk classes do NGeneBio Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for NGeneBio Co., Ltd.'s devices are IVDR Class C and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from NGeneBio Co., Ltd. in the registry?
The most recently registered devices listed for NGeneBio Co., Ltd. include HEMEaccuTest DNA, SOLIDaccuTest DNA, NGeneAnalySys and ONCOaccuPanel.