Accugene, Inc.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000058798
- Devices
- 8
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
AccuStool Collection Kit Ref ACN M41.01
Regimes: CE IVDR Registry: EUDAMEDAccuStool Collection Kit Ref ACN M41.01
Regimes: CE IVDR Registry: EUDAMEDAccuSaliva Collection Kit Ref ACN M11.02
Regimes: CE IVDR Registry: EUDAMEDAccuViral Collection Kit Ref ACN M61.01N
Regimes: CE IVDR Registry: EUDAMEDAccuSaliva Collection Kit Ref ACN M11.01
Regimes: CE IVDR Registry: EUDAMEDAccuViral Collection Kit Ref ACN M61.01
Regimes: CE IVDR Registry: EUDAMEDAccuSaliva Viral Collection Kit Ref ACN M61.02
Regimes: CE IVDR Registry: EUDAMEDAccuBuccal Collection Kit Ref ACN M21.01
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- KR-MF-000058798
- EUDAMED status
- Active
- EUDAMED registered name
- Accugene, Inc.
- EUDAMED abbreviated name
- Accugene
- Registered address
- 73, Gaetbeol-ro, Yeonsu-gu, 21999, Incheon, South Korea
- Website
- accugenelab.com
- [email protected]
- Phone
- +32 32 710 1603
- PRRC contact
- Hyeri KIM
Frequently asked questions
How many devices does Accugene, Inc. have in the registry?
The registry currently lists 8 devices for Accugene, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accugene, Inc.'s devices?
Among its 8 most recently registered devices, Accugene, Inc. has devices listed in EUDAMED (8 devices).
What risk classes do Accugene, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Accugene, Inc.'s devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Accugene, Inc. in the registry?
The most recently registered devices listed for Accugene, Inc. include AccuStool Collection Kit, AccuSaliva Collection Kit, AccuViral Collection Kit and AccuSaliva Viral Collection Kit.